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NCTID: NCT04800497

Title: The Role Of Circulating Tumor Cells As Markers Of Advanced Disease And Prognosis In HCC 
Study Summary: Hepatocellular carcinoma (HCC) recurs in up to 60% of patients who undergo resection. Circulating tumor cells (CTC) have been advocated as promotors of the recurrence. However, their role as prognostic markers in the surgical setting is unclear. The aim of the present study has been to assess the association between CTC from peripheral blood samples and the risk of recurrence after surgery.  Patients with a first diagnosis of HCC, no previous treatment for this condition, no other oncological history, and BCLC stage 0-A-B will be enrolled in 2 centers. Patients will undergo to serial liquid biopsies (i.e., a 15ml peripheral blood sample on each time point) at day 0-30-90-180-365 after surgery. After isolation of peripheral blood mononucleate cells, CTC will be detected by FACSymphony™ and subsequently the following markers will be identified: EpCAM, N-cadherin (N-cad) and CD90. Epithelial-mesenchymal transition (EMT) will be analyzed by an index estimated as the ratio between the number of EpCAM+ -cad- and EpCAM+ -cad+ cells (EMT Index). Patients will be divided according to the recurrence status. 
Sponsor: University of Milano Bicocca 
Intervention: Hepatic resection 
Start Date: 2019-02-07 
Last Updated: 2021-03-16 
Number of Patients: 200 
Recruitment Status: RECRUITING 
Condition: Hepatocellular Carcinoma 

NCTID: NCT02245854

Title: Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps 
Study Summary: Colorectal cancer is a major cause of morbidity and mortality in Western countries. Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC incidence and mortality.  Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel perforation, so that a careful balance between efficacy and safety appears to be clinically relevant.  Most of the polypectomies are performed for diminutive (<5 mm) or small (6-9 mm) lesions, which represent over 90% of all the polyps.  To minimize the risk of complications when removing <10 mm polyps, cold-polypectomy techniques - i.e. without electric current - by means of biopsy forceps or snare, have been proposed.  Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of electrocautery may result in an increased risk of bleeding. The safety of cold-snare polypectomy has however been recently shown in controlled trials.  Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual disease), and no studies have compared it to conventional polypectomy.  The investigators perform this study to assess both the efficacy and safety of a novel snare (Exacto™) for polyp removal. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Exacto™ 
Start Date: 2013-09 
Last Updated: 2014-09-22 
Number of Patients: 250 
Recruitment Status: COMPLETED 
Condition: Polyp of Large Intestine 

NCTID: NCT05403554

Title: A Study of NI-1801 in Patients With Mesothelin Expressing Solid Cancers 
Study Summary: Study LCB-1801-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), first-in-human clinical study of NI-1801 in subjects with advanced, metastatic, or recurrent solid malignancies expressing mesothelin (MSLN).  The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of NI-1801, administered intravenously (IV) to determine the maximum tolerated dose (MTD) and non-tolerated toxic dose (NTD) of both the first dose and subsequent doses of NI-1801.  The expansion part (Part B) will further evaluate the safety and efficacy of NI-1801 administered at or below the MTD in up to 20 subjects in order to determine the recommended Phase 2 dose (RP2D).  Treatments will be administered in 28-day cycles for up to 6 months until confirmed disease progression, unacceptable toxicity, or subject/Investigator decision to withdraw. NI-1801 treatment can extend beyond 6 cycles for those patients who do not have disease progression. 
Sponsor: Light Chain Bioscience - Novimmune SA 
Intervention: NI-1801 
Start Date: 2022-04-29 
Last Updated: 2023-05-30 
Number of Patients: 40 
Recruitment Status: RECRUITING 
Condition: Epithelial Ovarian Cancer 

NCTID: NCT04949256

Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014) 
Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma  The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-07-28 
Last Updated: 2023-11-24 
Number of Patients: 862 
Recruitment Status: RECRUITING 
Condition: Metastatic Esophageal Squamous Cell Carcinoma 

NCTID: NCT05876754

Title: An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma 
Study Summary: A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle. 
Sponsor: Servier Affaires Médicales 
Intervention: Ivosidenib Oral Tablet 
Start Date: 2023-05-03 
Last Updated: 2023-09-06 
Number of Patients: 220 
Recruitment Status: RECRUITING 
Condition: Cholangiocarcinoma 

NCTID: NCT04203667

Title: EndoRotor® Endoscopic Mucosal Resection System for the Colon 
Study Summary: The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.  In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base. 
Sponsor: Interscope, Inc. 
Intervention: EndoRotor Resection 
Start Date: 2018-04-18 
Last Updated: 2022-04-05 
Number of Patients: 66 
Recruitment Status: COMPLETED 
Condition: Polyp of Colon 

NCTID: NCT02616887

Title: Study of Image-Guided SBRT for Vertebral Metastases 
Study Summary: Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid tumors, investigators have designed this study to assess feasibility of SBRT in selected patients with spine metastases. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Single dose SBRT and VMAT technique 
Start Date: 2015-11-05 
Last Updated: 2022-05-09 
Number of Patients: 26 
Recruitment Status: TERMINATED 
Condition: Vertebral Metastases 

NCTID: NCT02246322

Title: A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions. 
Study Summary: Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from the GI wall lesions and from organs adjacent to the GI tract (pancreas, nodes…).Needles available for EUS-FNA include 25G, 22G and 19G. Some studies have suggested that the 25G needle could be equal or even better than the 22G needle.  The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles types, 25G and 22G. 
Sponsor: Istituto Clinico Humanitas 
Intervention: 25G needle 
Start Date: 2013-08 
Last Updated: 2014-09-22 
Number of Patients: 144 
Recruitment Status: UNKNOWN 
Condition: Pancreatic Cancer 

NCTID: NCT03834519

Title: Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) 
Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5’-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy.  The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to:  # Overall Survival (OS) and # Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR)  As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2019-05-02 
Last Updated: 2023-11-07 
Number of Patients: 793 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Prostatic Neoplasms 

NCTID: NCT02231385

Title: Acetic Acid Colonoscopy Enhancement Study 
Study Summary: The purpose of this study is to compare the additional diagnostic yield obtained by using the acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy.  Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two “back-to-back” procedures limited to the examination of the right colon.  Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.  Results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for serrated lesions. Secondary outcome measures will include adenoma detection rate in the right colon or other locations, characteristics of polyps detected, including size and histological results.  Subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Acetic Acid 
Start Date: 2014-09 
Last Updated: 2014-09-04 
Number of Patients: 500 
Recruitment Status: UNKNOWN 
Condition: Colorectal Cancer 

NCTID: NCT02907385

Title: Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing 
Study Summary: LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored.  RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. The risk of postoperative anastomotic leakage varies widely depending on the level of anastomosis while the risk is higher in low anastomosis.  In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal and coloanal anastomoses performed within 10 cm from the anal verge.  STUDY DESIGN: This study is designed as a prospective, multi-center, multinational randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of this study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change in overall anastomotic leak rates in subjects undergoing low anterior resection with an anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery.  SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of post-operative leaks and additional benefits that could be related to the use of LifeSeal™ Kit such as reducing the severity and improving the outcome of a leak once it has occurred. In addition, the study will allow for collection and analysis of additional safety data and usability assessment of the device, medical resource utilization, and health related quality of life measures. 
Sponsor: LifeBond Ltd. 
Intervention: LifeSeal™ Kit 
Start Date: 2016-11 
Last Updated: 2018-03-30 
Number of Patients: 736 
Recruitment Status: UNKNOWN 
Condition: Rectal Cancer 

NCTID: NCT02984033

Title: Quality of Life and Psycological Evaluation of Patients Affected by Head and Neck Cancer 
Study Summary: The prospective trial is to describe the quality of life and psychological effects in patients with head and neck tumor receiving curative intent treatment 
Sponsor: Michele Tedeschi 
Intervention: Head and Neck patients 
Start Date: 2016-11 
Last Updated: 2018-10-24 
Number of Patients: 0 
Recruitment Status: WITHDRAWN 
Condition: Quality of Life 

NCTID: NCT03807947

Title: Radial Versus Femoral Access for Superselective Embolization of Hepatocellular Carcinoma 
Study Summary: The aim of this prospective, randomized study is to compare TRA vs TFA for superselective embolization of HCC using bland microparticles performed by multiple operators.  In particular, main objectives are to compare:  # the success rates of TRA and TFA including crossing over events between techniques # the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization # access-related adverse events # patient preference and reported discomfort 
Sponsor: Humanitas Clinical and Research Center 
Intervention: Radial TAE - Bland embolization with 40-100 Microparticles 
Start Date: 2019-01 
Last Updated: 2019-01-17 
Number of Patients: 74 
Recruitment Status: UNKNOWN 
Condition: Hepatocellular Carcinoma 

NCTID: NCT05591287

Title: Contrast Enhanced Harmonic Endoscopic Ultrasound (CH-EUS), Elastography, and Fractal Analysis in Predicting Pancreatic Cancer Aggressiveness and Response to Therapy. 
Study Summary: Contrast enhanced harmonic Endoscopic Ultrasound (CH-EUS) can be used during a conventional EUS examination to correctly identify and target lesions with the help of Ultrasound Contrast Agents. When CH-EUS is applied to the dynamic ultrasound images of conventional EUS, additional information about tumour vascularity can be obtained solely from the visual uptake of contrast agent into the tumour. Angiogenesis within malignant tumour tissue is varied from that of its normal surrounding tissue.Blood flow within malignant tissue is characteristically low volume. Contrast agents are slow to pass through tumour microvasculature and hence this is seen as an area of hypo-enhancement. This hypo-enhancement or hypo-vascularity is well demonstrated in PDAC and the opposite is known to be true for PNET, both of these findings showing to be consistent with cytopathological results.Tumour hemodynamics and vascular patterns resultant from contrast uptake can be analysed further with the help of fractal use. Attaining this information can allow more accurate characterization of both PDAC and PNET thus in turn predicting their respective behaviours i.e., aggressiveness (local or systemic spread) and histological grade. (6)  Contrast-enhanced computer tomography (CT) is currently used to evaluate the response of chemotherapy in patients with PDAC according to the RECIST guidelines. However, one significant advantage of CH-EUS over dynamic CT imaging is that ultrasound contrast agents do not leak into the interstitial space allowing for better quantitative measurement of tissue perfusion.More recently, the EFSUMB guidelines have recommended dynamic CH-EUS as a preferred technique to monitor anti-angiogenic treatment.This founds the basis for evaluating CH-EUS’s role. *(with the help of fractal analysis)-remove this if needed* in predicting PDAC’s response to neo-adjuvant chemotherapy as this is yet to be evaluated.  Yamashita et al. demonstrated that patients with PDAC with positive vessel sign showed a significantly longer progression free survival compared with patients with negative vessel sign after chemotherapy (P = 0.037; log-rank test).  EUS elastography (EUS-E) is a US technique that measures the hardness of tissues. The level of hardness of SPLs can be evaluated using qualitative scores and/or quantitative methods (strain ratio <math display="block">SR</math>). 
Sponsor: Istituto Clinico Humanitas 
Intervention: Contrast enhanced harmonic Endoscopic Ultrasound 
Start Date: 2022-10-01 
Last Updated: 2022-10-24 
Number of Patients: 100 
Recruitment Status: RECRUITING 
Condition: Pancreatic Mass 

NCTID: NCT02391207

Title: Hepatic Vein-sparing Hepatectomy for Colorectal Liver Metastases at the Caval Confluence 
Study Summary: Major hepatectomies are generally selected for tumors involving the hepatic vein (HV) at the caval confluence (CC). As alternative, HV reconstruction has been proposed. The present study aimed to evaluate the feasibility and safety of a HV-sparing policy guided by intraoperative ultrasonography (IOUS) in a cohort of patients having at least one colorectal liver metastasis (CLM) in contact with a HV at CC. HV section can be avoided in the large majority of cases thanking to CLMs detachment or to HV partial resection or reconstruction: this policy seems feasible, safe, reduces the need of major hepatectomies, and oncologically provides an adequate local control. 
Sponsor: University of Milan 
Intervention: Hepatic vein-sparing hepatectomy 
Start Date: 2009-01 
Last Updated: 2015-03-18 
Number of Patients: 50 
Recruitment Status: COMPLETED 
Condition: Secondary Malignant Neoplasm of Liver 

NCTID: NCT04662710

Title: Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015) 
Study Summary: The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer.  The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2020-12-30 
Last Updated: 2023-09-08 
Number of Patients: 890 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced/Metastatic Gastroesophageal Adenocarcinoma 

NCTID: NCT05297162

Title: PSMA PET/CT vs. mpMRI in Patients With a High Suspicion of Prostate Cancer: a Head to Head, Parallel, Prospective Trial 
Study Summary: This is prospective single-arm case-control study designed to compare in parallel PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy (“experimental test”) with mpMRI/TRUS fusion prostate biopsy (“standard test”) in men with a high suspicion of PCa after at least one negative biopsy. 
Sponsor: Istituto Clinico Humanitas 
Intervention: PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy 
Start Date: 2022-04-01 
Last Updated: 2022-04-28 
Number of Patients: 128 
Recruitment Status: RECRUITING 
Condition: Prostate Cancer 

NCTID: NCT04637893

Title: The Impact of Covid-19 Pandemic on Colorectal Cancer Prevention Due to Delays in Diagnosis: a Global Study 
Study Summary: Screening programs have been associated with a substantial reduction in colorectal cancer (CRC) mortality through endoscopic resection of preneoplastic lesions and detection of early-stage invasive cancers.  In March 2020, the World Health Organization declared as a pandemic the outbreak of coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2. Since then, the SARS-CoV-2 have never stopped spreading, causing an unprecedented situation with highly restrictive considerations to be adopted by the majority of countries worldwide.  Health-care facilities have been making an enormous effort to assist patients affected by COVID-19, while adopting measures to maintain a safe environment for patients and healthcare professionals. As a result, the usual workflow in endoscopy departments changed dramatically, leading to an increase in cancelled procedures, probably increasing the future burden of Colorectal Cancer due to delays in diagnosis. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Colonoscopy 
Start Date: 2020-12-16 
Last Updated: 2022-06-08 
Number of Patients: 1000 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT03834493

Title: Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641) 
Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses.  Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS).  Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2019-07-28 
Last Updated: 2023-06-15 
Number of Patients: 1244 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Prostatic Neoplasms 

NCTID: NCT05693116

Title: Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule 
Study Summary: The goal of this observational study is to learn about survival and prognostic factors in patients who underwent surgical treatment for primary squamous cell carcinoma of the nasal vestibule. The main questions it aims to answer are:  * what is the prognosis of patients affected by squamous cell carcinoma of the nasal vestibule? * are there any specific factors that could influence prognosis? * is it possible to elaborate a new staging system, able to overcome the limitations of the currently used ones? Data about patients, tumour and type of surgery performed will be collected. Participants will be followed-up for a minimum 6 months period after surgery. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Rhinectomy 
Start Date: 2022-12-01 
Last Updated: 2023-01-20 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: Nasal Vestibule Carcinoma 

NCTID: NCT03797326

Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) 
Study Summary: The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2019-02-12 
Last Updated: 2023-10-31 
Number of Patients: 590 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced Solid Tumors 

NCTID: NCT03221426

Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) 
Study Summary: The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.  The primary study hypotheses are that:  * Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and * Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2017-10-09 
Last Updated: 2023-09-22 
Number of Patients: 1007 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Gastric Cancer 

NCTID: NCT03650517

Title: Minimally Invasive Right Colectomy Anastomosis Study 
Study Summary: Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.  A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.  However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.  MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:  # Robotic Right Colectomy with ICA # Robotic Right Colectomy with ECA # Laparoscopic Right Colectomy with ICA # Laparoscopic Right Colectomy with ECA  All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery. 
Sponsor: Instituto de Investigación Marqués de Valdecilla 
Intervention: Extracorporeal Anastomosis 
Start Date: 2018-11-01 
Last Updated: 2019-09-25 
Number of Patients: 1200 
Recruitment Status: UNKNOWN 
Condition: Colorectal Cancer 

NCTID: NCT03834506

Title: Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921) 
Study Summary: The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).  There are two primary study hypotheses.  Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).  Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2019-05-02 
Last Updated: 2023-08-25 
Number of Patients: 1030 
Recruitment Status: COMPLETED 
Condition: Prostatic Neoplasms 

NCTID: NCT05464706

Title: Study on the Quality of Life (QoL) After Liver Surgery 
Study Summary: Liver cancer in adult men is the fifth most frequently diagnosed cancer worldwide, and is the second leading cause of cancer-related death in the world. To date, liver surgery is the treatment of choice for those patients with resectable disease. However, still today the proportion of resectable patients is limited due to a large proportion of patients presenting with advances disease. For these patients, the treatment consists of systemic chemotherapy, which unfortunately is associated with median survival of 12 months. The choice of the appropriate treatment scheme adheres to the standard guidelines based on the results of clinical trials. Of note, in case of HCC and MFCCC very few international approved therapeutic guidelines are available. In particular, there is no agreement among specialists about the use of chemotherapy as adjuvant treatment after hepatic resection for HCC or MFCCC. An important aspect of the postoperative “adjuvant therapy” is the possibility to enhance the recovery after the operation. Indeed, the possibility to accelerate the functional recovery in a patient who receives a major cancer operation is of paramount importance. In this sense, having a product that might help the patients’ recovery should be one of the priorities of the medical and pharmaceutical industry. To our knowledge, there are no previous studies that investigated such an important aspect. 
Sponsor: Humanitas Clinical and Research Center 
Intervention: Synchrolevels 
Start Date: 2018-01-01 
Last Updated: 2022-08-04 
Number of Patients: 60 
Recruitment Status: COMPLETED 
Condition: Hepatocarcinoma 

NCTID: NCT05645679

Title: Efficacy and Safety of HYbrid Argon Plasma Coagulation Technique in Patients With Barrett’s Esophagus-Related Dysplasia 
Study Summary: Background Barrett’s esophagus (BE) is defined by AGA as “a change in the esophageal epithelium of any length that can be recognized at upper endoscopy and is confirmed to have intestinal metaplasia by biopsy”. It is a pre-malignant condition and may progress to low grade dysplasia, high grade dysplasia and ultimately esophageal adenocarcinoma which has poor prognosis with a 5-year survival rate of only 5-20%.Radiofrequency ablation (RFA) is a standard modality and well-studied endoscopic treatment for dysplastic BE. While the rate of complete eradication of dysplasia has been reported to be between 78% - 94% with RFA, the rate of complications associated with this procedure has been reported to be as high as 19.1%, and the costs are high. In a randomized clinical trial in patients with BE and low-grade dysplasia by Phoa et al in 2014, 68 patients underwent radiofrequency ablation therapy with a median of three ablation sessions per patient while 68 patients were randomized to endoscopic surveillance. In this study, a total of 13 patients (19.1%) experienced an adverse event in the treatment group versus no adverse events in the control group. Eight patients (11.8%) developed esophageal strictures which required a median of one dilation, three patients were noted to have small mucosal lacerations, one patient developed retrosternal pain treated with analgesics while one patient developed abdominal pain requiring hospitalization and treatment with analgesia. Several other studies have reported the rate of complications ranging between 5% to 19.1% and stricture formation being the most common among them. Hybrid argon plasma coagulation (H-APC) is a newer technique that involves submucosal fluid injection prior to performing APC. The injection of solutions (e.g., 0.9% sodium chloride solution (normal sterile saline) with or without supplementation of epinephrine, methylcellulose solution, hydroxyethyl starch, hyaluronic acid, autologous blood or blood substitute fluids) into the submucosa to limit the depth of thermal injury has been established both in pre-clinical studies for different tissues of the gastrointestinal tract and in the clinical practice for EMR and ESD, respectively. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Hybrid Argon Plasma Coagulation System 
Start Date: 2021-04-02 
Last Updated: 2022-12-09 
Number of Patients: 50 
Recruitment Status: RECRUITING 
Condition: Barrett’s Esophagus 

NCTID: NCT03158779

Title: Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer 
Study Summary: The aim of this phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT in patients with unresectable pancreatic cancer. 
Sponsor: Istituto Clinico Humanitas 
Intervention: SBRT and chemotherapy 
Start Date: 2017-05-10 
Last Updated: 2022-09-15 
Number of Patients: 45 
Recruitment Status: COMPLETED 
Condition: Pancreatic Cancer 

NCTID: NCT03425643

Title: Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671) 
Study Summary: This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery <math display="block">neoadjuvant phase</math>, followed by pembrolizumab alone after surgery <math display="block">adjuvant phase</math> in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2018-04-24 
Last Updated: 2023-11-13 
Number of Patients: 797 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT06137833

Title: Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Adjuvant Chemotherapy 
Study Summary: The goal of this clinical trial is to test the effect of the administration of APPORTAL® in addition to the SoC (recommended physical exercise), in patients with breast cancer, suffering from fatigue during adjuvant chemotherapy. The main questions it aims to answer are:  * if the food supplement APPORTAL® can be of help in supporting the physiological energy level, against the fatigue symptom in cancer patients undergoing adjuvant chemotherapy; * if the supplementation with APPORTAL® can optimize the nutritional status, the muscular strength, the quality of life of the patient.  Also, the patients’ satisfaction on the product received, the adherence to treatment will be evaluated and the overall safety and tolerability of the study product.  The patients will be asked to perform 3 study visits from baseline to the end of treatment (at 4 and 8 weeks after baseline) and a follow-up visit after 12 weeks from baseline.  The main assessments at each visit will be:  * physical examination, weight, Body Mass Index (BMI), body temperature (°C), heart rate, respiratory frequency, and systolic and diastolic blood pressure; * previous and concomitant treatments; * fatigue assessment through BFI questionnaire; * quality of life through questionnaire SF-12; * muscular strength (dynamometer) * Adverse Event check (from Visit 2) Moreover, at visit 1 (baseline) and at visit 3 (end of treatment) a blood sample will be collected to evaluate the blood metabolites.  Telephonic follow-up will be done at 2 weeks, 6 weeks, 10 weeks to assess compliance and to recommendations on physical activity and to study treatment (only at 2 and 6 weeks) and tolerability/safety.  Participants will receive the nutrition supplement or the placebo, in addition to the SoC (recommended physical exercise), for 8 weeks.  Researchers will compare Apportal® and Placebo groups to see if the physiological energy level against the fatigue symptom, the nutritional status, the muscular strength, the quality of life of the patient improve after 8 weeks of treatment with APPORTAL® in addition to SoC (recommended physical exercise). 
Sponsor: Pharmanutra S.p.a. 
Intervention: APPOPRTAL® 
Start Date: 2023-11-27 
Last Updated: 2023-11-18 
Number of Patients: 92 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Fatigue 

NCTID: NCT05732233

Title: RITUAL Ultivision AI CADe Randomized Controlled Trial 
Study Summary: Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas).  Ultivision AI CADe is indicated for white light colonoscopy only. 
Sponsor: Satisfai Health, Inc. 
Intervention: Ultivision AI 
Start Date: 2023-04-03 
Last Updated: 2023-02-21 
Number of Patients: 1100 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Colon Adenoma 

NCTID: NCT04053231

Title: Hepatocarcinoma Recurrence on the Liver Study - Part2 
Study Summary: Rationale for the trial. To evaluate the impact of surgery on hepatocarcinoma recurrence. Thus, to evaluate the impact of different clinical, radiological, histopathological variables on recurrence after surgical treatment. The nature of this study will allow to observe, over time, the distribution of the considered collection variables, allowing a strictly observational monitoring of possible associations able to suggest models or interpretations, which can then be the basis for the construction of prospective and randomized studies. 
Sponsor: University of Milano Bicocca 
Intervention: liver resection 
Start Date: 2019-09 
Last Updated: 2019-08-12 
Number of Patients: 3000 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Liver Cancer 

NCTID: NCT04260321

Title: The AID Study 2: Artificial Intelligence for Colorectal Adenoma Detection 2 
Study Summary: Colonoscopy is clinically used as the gold standard for detection of colon cancer (CRC) and removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there exists a disappointing level of adenomas missed at colonoscopy. “Back-to-back” colonoscopies have indicated significant miss rates of 27% for small adenomas (< 5 mm) and 6% for adenomas of more than 10 mm in diameter. Studies performing both CT colonography and colonoscopy estimate that the colonoscopy miss rate for polyps over 10 mm in size may be as high as 12%. The clinical importance of missed lesions should be emphasized because these lesions may ultimately progress to CRC.  Limitations in human visual perception and other human biases such as fatigue, distraction, level of alertness during examination increases such recognition errors and way of mitigating them may be the key to improve polyp detection and further reduction in mortality from CRC. In the past years, a number of CAD systems for detection of polyps from endoscopy images have been described. However, the benefits of traditional CAD technologies in colonoscopy appear to be contradictory, therefore they should be improved to be ultimately considered useful. Recent advances in artificial intelligence (AI), deep learning (DL), and computer vision have shown potential to assist polyp detection during colonoscopy.  Average experienced endoscopists (each having performed <2000 screening colonoscopies) will perform the endoscopic procedure. 
Sponsor: Istituto Clinico Humanitas 
Intervention: AI 
Start Date: 2020-02-19 
Last Updated: 2021-02-05 
Number of Patients: 700 
Recruitment Status: COMPLETED 
Condition: Colon Cancer 

NCTID: NCT05611151

Title: Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy 
Study Summary: This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC).  Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy :  * Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group) * Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group) 
Sponsor: NEC Corporation 
Intervention: Computer Aided Detection (CADe) 
Start Date: 2023-04-30 
Last Updated: 2023-03-28 
Number of Patients: 700 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Colorectal Cancer 

NCTID: NCT02961686

Title: Quality of Life and Sexuality in Patients With Prostate Cancer 
Study Summary: The trial is to describe quality of life in patients affected by prostate cancer treated with exclusive radiotherapy and submitted to psychological and andrologic evaluation. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Patients affected by prostate cancer 
Start Date: 2019-07-16 
Last Updated: 2019-07-23 
Number of Patients: 0 
Recruitment Status: WITHDRAWN 
Condition: Quality of Life 

NCTID: NCT04659148

Title: Surgical and Oncological Outcomes in Patients With Ulcerative Colitis-associated Rectal Cancer 
Study Summary: This is a retrospective observational study to investigate the short-term surgical outcomes, and long-term oncological outcomes of patients diagnosed with Ulcerative colitis and rectal cancer. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Total proctocolectomy 
Start Date: 2020-10-01 
Last Updated: 2020-12-09 
Number of Patients: 40 
Recruitment Status: UNKNOWN 
Condition: Ulcerative Colitis 

NCTID: NCT02615665

Title: Intratumoral CD3+ and NKp46+ Cells in Colorectal Liver Metastases 
Study Summary: The long-term outcome of patients resected for colorectal liver metastases (CLM) after neoadjuvant chemotherapy (CHT) depends by several tumoral and non-tumoral factors, such as the immune response to the tumor and to the CHT. The aim of this study was to investigate the impact of the pathological and immunological response in patients undergoing liver resection for CLM after CHT in regards to the long-term outcome. 
Sponsor: University of Milan 
Intervention: Hepatic resection 
Start Date: 2013-01 
Last Updated: 2015-11-26 
Number of Patients: 121 
Recruitment Status: COMPLETED 
Condition: Colorectal Liver Metastases 

NCTID: NCT04586231

Title: A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) 
Study Summary: This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy.  The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Belzutifan 
Start Date: 2021-02-25 
Last Updated: 2023-08-14 
Number of Patients: 708 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Carcinoma, Renal Cell 

NCTID: NCT06069453

Title: Hyaluronic Acid Sodium Salt and Hydeal-D in the Management of LUTS After TURBT for NMIBC. 
Study Summary: This will be an open-label, prospective, single-centre, randomised, controlled, parallel-group medical device investigation. The investigational plan will include four visits in total at the investigational site. One visit (Visit 2) will consist in the hospitalisation period and will last 3/4 days. Patients will be admitted to hospital in the day preceding the TURBT (Day -1; in case the TURBT is programmed in the morning) or in the day of the TURBT (Day 0; in case the TURBT is programmed in the afternoon) and will stay in the hospital for 3/4 days after the intervention (performed on Day 0). Patients will then be discharged, if considered as appropriate based on Investigator’s judgment, following the removal of the catheter and the first clear urination. Patients will be asked to remain in the same geographic area of the investigational site up to the end of study visit. 
Sponsor: Fidia Farmaceutici s.p.a. 
Intervention: Hyaluronic Acid (HA) sodium salt and Hydeal-D 
Start Date: 2020-08-19 
Last Updated: 2023-10-05 
Number of Patients: 54 
Recruitment Status: TERMINATED 
Condition: Non-muscle Invasive Bladder Cancer (NMIBC) 

NCTID: NCT02323360

Title: A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC 
Study Summary: The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle. 
Sponsor: Istituto Clinico Humanitas 
Intervention: SBRT 
Start Date: 2014-11 
Last Updated: 2019-10-25 
Number of Patients: 41 
Recruitment Status: TERMINATED 
Condition: Hepatocellular Carcinoma 

NCTID: NCT04783961

Title: Cold Snare Endoscopic Resection for Duodenal Adenomas 
Study Summary: Non-ampullary sporadic duodenal adenomas (SDA) are rare lesions, incidentally discovered in up to only 5% of patients during routine endoscopy. In any case, these lesions require treatment due to their potential malignant transformation because of the adenoma-carcinoma sequence, occurring in 30-85% of cases. Endoscopic resection (ER) of SDA represents an attractive alternative to surgical resection in appropriately selected patients, with lower morbidity and mortality rates.  However, most endoscopists are not keen to resect larger lesions due to the risk of complications. Indeed, endoscopic resection in the duodenum has unique challenges: thin wall, high vascularity, very limited space and harmful effects of bile and acid both acting on the ER defect.  Cold snare endoscopic resection has been shown to be a viable method for removing colorectal lesions with comparable efficacy outcomes compared to conventional polypectomy/endoscopic mucosal resection (EMR) and a promising safety profile. As a matter of fact, adverse events associated with hot snare resection technique such as delayed bleeding, post-polypectomy syndrome, and perforation are all related to electrocautery-induced injury.  Performing cold snare piece-meal resection and avoiding the need of thermal therapy, may have a major impact in the duodenum where the risk of delayed bleeding and perforation is consistent.  The aim of this pilot study is to prospectively evaluate the feasibility and the efficacy in term of safety and efficacy of cold snare endoscopic resection. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Cold snare endoscopic resection 
Start Date: 2021-03-01 
Last Updated: 2022-09-15 
Number of Patients: 10 
Recruitment Status: COMPLETED 
Condition: Duodenal Adenomas 

NCTID: NCT05903261

Title: Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors 
Study Summary: This prospective observational study aims to investigate the effectiveness and safety of SBRT in the management of oligometastases from rare tumors. In addition, the study aims to identify potential differences in treatment efficacy and toxicity between different types of cancer and to provide valuable information on the use of SBRT in these contexts, potentially leading to better treatment options and outcomes for these patients. 
Sponsor: Istituto Clinico Humanitas 
Intervention: SBRT 
Start Date: 2023-06 
Last Updated: 2023-06-15 
Number of Patients: 200 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Oligometastatic Disease 

NCTID: NCT04455438

Title: SBRT Dose Escalation for Reirradiation of Inoperable Lung Lesions 
Study Summary: Prospective phase I study to evaluate the maximum tolerated dose (MTD) of SBRT for thoracic re-irradiation. Dose limiting toxicity will be pneumonitis ≥ G3. The potential advantage of the dose escalation planned in this study is the delivery of an ablative dose to radically treat patients with inoperable local relapse, without unacceptable toxicity. 
Sponsor: Istituto Clinico Humanitas 
Intervention: SBRT dose escalation 
Start Date: 2020-05-28 
Last Updated: 2022-09-15 
Number of Patients: 15 
Recruitment Status: RECRUITING 
Condition: Non Small Cell Lung Cancer 

NCTID: NCT04571294

Title: Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy 
Study Summary: Pancreaticoduodenectomy (PD) associated with lymphadenectomy is the only curative option for patients affected by pancreatic ductal adenocarcinoma (PDAC). In 2014, the International Study Group on Pancreatic Surgery (ISGPS) defined the “standard lymphadenectomy”, that is mandatory during PD for PDAC. Lymphadenectomy should include the removal of the hepatoduodenal ligament nodes (stations 5, 6, 12b1, 12b2, 12c according the classification of Japanese Pancreas Society), nodes along the hepatic artery (station 8a), the posterior surface of the pancreatic head (station 13a and 13b), the superior mesenteric artery (14a right lateral side, 14b right lateral side) and nodes of the anterior surface of the pancreatic head (stations 17a and 17b). The inclusion of para-aortic lymphnodes (PALN) (station 16) in standard lymphadenectomy is still matter of debate. Moreover, some retrospectives or prospective studies reported that the presence of PALN metastases has a significant negative prognostic impact. Until now, no randomized studies comparing PD associated with standard lymphadenectomy with or without removal of PALN have been published. The aim of this study is to evaluate if the removal of station 16 should be routinely included in standard lymphadenectomy during PD for PDAC. 
Sponsor: Humanitas Hospital, Italy 
Intervention: removal of para-aortic lymphnodes (PALN) 
Start Date: 2020-05-26 
Last Updated: 2020-10-01 
Number of Patients: 180 
Recruitment Status: RECRUITING 
Condition: Pancreas Cancer 

NCTID: NCT04695262

Title: EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors 
Study Summary: The differentiation among the Gastrointestinal Subepithelial Tumors (SETs) represents a clinical challenge. Endoscopic Ultrasound (EUS) alone may be ineffective in differentiating SETs subtypes, and tissue sampling of these lesions may be technically difficult. EUS Elastography (EUS-E) has been applied to many gastrointestinal diseases, providing a qualitative/semi-quantitative stiffness analysis, but only few studies have examined the role of EUS-E in the diagnosis of SETs. In addition, the use of contrast agents has improved the diagnostic performance of the EUS, especially in the differentiation between GISTs and other gastrointestinal SETs.  The aim of the study is to examine the performance of EUS-E and Contrast Enhanced-EUS (CE-EUS) in distinguishing among different gastrointestinal SETs subtypes. EUS patterns of different techniques will be compared to the final diagnosis gained by the analysis of histopatological specimens (surgical resection or EUS-FNB) or imaging/clinical follow-up. 
Sponsor: Istituto Clinico Humanitas 
Intervention: EUS-FNB 
Start Date: 2021-01-27 
Last Updated: 2023-03-21 
Number of Patients: 50 
Recruitment Status: RECRUITING 
Condition: Gastrointestinal Subepithelial Tumors 

NCTID: NCT05015010

Title: Alectinib in Neo-adjuvant Treatment of Stage III NSCLC 
Study Summary: Stage III NSCLC is a heterogeneous group of tumors with a wide spectrum of clinical presentations. Across this wide spectrum of heterogeneity, there is no single definitive therapeutic approach and the definition of the most effective treatment approach needs a multidisciplinary approach. In this trial we want to test in ALK positive stage III locally advanced NSCLC patients, the efficacy of Alectinib to induce tumor shrinkage when administered before surgery and to reduce the possibility of disease recurrence, with a limited risk of toxicity related, in long term administration after surgery. 
Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica 
Intervention: Alectinib 
Start Date: 2021-05-20 
Last Updated: 2022-10-03 
Number of Patients: 33 
Recruitment Status: RECRUITING 
Condition: Non Small Cell Lung Cancer 

NCTID: NCT05730192

Title: EAGLE Trial CADDIE Artificial Intelligence Endoscopy 
Study Summary: The EAGLE study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the CADDIE device and to confirm that the device performs as expected. 
Sponsor: Odin Medical 
Intervention: CADDIE 
Start Date: 2023-05-10 
Last Updated: 2023-09-28 
Number of Patients: 950 
Recruitment Status: RECRUITING 
Condition: Colorectal Cancer 

NCTID: NCT05977673

Title: Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy 
Study Summary: This is a multicenter, prospective, non-randomized, open-label, phase 2 clinical study to evaluate the efficacy and safety of tislelizumab in patients with de novo Hodgkin Lymphoma deemed ineligible to frontline chemotherapy. 
Sponsor: Fondazione Italiana Linfomi - ETS 
Intervention: Tislelizumab 
Start Date: 2023-12 
Last Updated: 2023-11-24 
Number of Patients: 28 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Hodgkin Lymphoma 

NCTID: NCT05725473

Title: Clinical Efficacy and Safety of Endoscopic Dilatation With Eso-Filp in Benign Esophageal Strictures 
Study Summary: Benign esophageal strictures are frequently seen in endoscopic practice and are caused by a variety of esophageal disorders, including peptic, radiotherapy-induced and caustic injuries, Schatzki ring, eosinophilic esophagitis (EoE), and strictures after surgical resection (anastomotic) or endoscopic resection (endoscopic mucosal resection-EMR- and endoscopic submucosal dissection-ESD), and ablative therapies (Radiofrequency, Cryotherapy and Argon-plasma coagulation).  Endoscopic dilation is the first treatment step for benign esophageal strictures. Two types of dilators are available, namely, through-the-scope balloon dilators, with or without a guidewire, and wire-guided bougie dilators. Bougie dilators are used for simple strictures and for strictures in the proximal esophagus, especially anastomotic strictures. Bougie dilators exert a combined radial and longitudinal force, which may increase the risk of perforation. Bougie dilators allow, however, sensing the degree of resistance during dilation, and thereby help determining increasing bougie sizes during next-step dilations. Through the-scope balloon dilators are preferred for complex strictures. Balloons dilators allow direct visualization and control of the radially applied dilation force. In literature, both dilation techniques appear to be equally effective and safe in the management of esophageal strictures, showing no differences in terms of risks of AEs About 30 years ago, the “rule of three” has been published. This rule dictated the extent of dilation during any endoscopic session (i.e., no more than three dilators successively larger than the first dilator to meet resistance were passed) and has been used by endoscopists to reduce the risk of perforation. However, the safety of the “rule of three” has never been demonstrated. Moreover, a recent study suggests that more than three dilation steps per session may be considered for esophageal strictures, with the exception of malignant strictures. The EsoFLIP (Medtronic Inc., Shoreview, MN, USA) is a novel dilation balloon that provides real-time, objective visualization and monitoring of therapeutic dilation. EsoFLIP utilizes high-resolution impedance planimetry to provide real-time measurements (diameter and cross-sectional area) of the stenotic area before, during, and at the end of the dilation without the need of fluoroscopy.  In 2013, technical feasibility and safety of the EsoFLIP in esophago-gastric junction (EGJ) dilation have been demonstrated on porcine models. In a small first pilot study, the technical feasibility of the EsoFLIP device in 10 patients with achalasia has been demonstrated. A second study reported short-term efficacy, both objective (improvement in barium column) and subjective (improvement in Eckardt score), in 28 patients managed using the FLIP hydraulic balloon dilator. Very limited data are currently available in the literature on the use of EsoFLIP in benign esophageal strictures dilation. Potential advantages of the use of EsoFLIP are dilation without fluoroscopy and associated radiation, control of dilation sizes to generate the desired dilation effect and assessment of stricture size and the response to dilatation immediately following dilation.  In a small single centre retrospective study on 19 paediatric patients, use of EsoFLIP hydraulic dilation was safe and provided a larger diameter increase compared with standard balloon dilation, but this was not statistically significant likely because of the small cohort size. The study also suggested that procedure time and fluoroscopy time were shorter in the EsoFLIP cases when compared to other traditional dilation methods. Esophageal dilation using EsoFLIP may yield a larger diameter change increasing the interval between a dilatation procedure and the following one and may potentially reduce procedure time when compared to traditional balloon dilation.  There is currently no published prospective study about dilation with EsoFLIP in adult patients affected by benign esophageal strictures. The endoluminal functional lumen imaging probe, EndoFLIP™ (Medtronic, Minneapolis, MN, USA) (FLIP), is a tool that utilizes impedance planimetry, a technique for performing balloon distention in the alimentary track, to obtain dynamic measurements of any sphincters including the diameter, cross-sectional area (CSA), and distensibility index (DI). Diseases where Endo-FLIP has been employed include esophageal stenosis, reflux esophagitis, eosinophilic esophagitis, gastroparesis, anal sphincter disease, achalasia, and it has also been used in peroral endoscopic myotomy. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Eso-Flip 
Start Date: 2023-01-12 
Last Updated: 2023-02-13 
Number of Patients: 15 
Recruitment Status: RECRUITING 
Condition: Esophageal Cancer 

NCTID: NCT04191096

Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) 
Study Summary: This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment until meeting protocol-specified discontinuation criteria if deriving clinical benefit. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2020-02-12 
Last Updated: 2023-11-18 
Number of Patients: 1251 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Hormone-Sensitive Prostate Cancer 

NCTID: NCT03742895

Title: Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002) 
Study Summary: This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1) have progressed or been intolerant to standard of care therapy; and 2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Olaparib 
Start Date: 2018-12-12 
Last Updated: 2023-11-24 
Number of Patients: 390 
Recruitment Status: RECRUITING 
Condition: Advanced Solid Neoplasms 

NCTID: NCT03742232

Title: Study Comparing the Bowel Cleansing Efficacy of PLENVU® Versus SELG-ESSE® Using a 2-Day Split Dosing Regimen. 
Study Summary: This study is a multicentre randomized parallel group phase IV study comparing the bowel cleansing efficacy, safety and tolerability of PLENVU® (a 1 litre PEG Bowel Cleansing Solution) versus SELG-ESSE® (a 4 litre PEG Bowel Cleansing Solution) using a 2-Day Split Dosing Regimen. 
Sponsor: Istituto Clinico Humanitas 
Intervention: PEG3350 
Start Date: 2018-10-31 
Last Updated: 2020-08-27 
Number of Patients: 399 
Recruitment Status: COMPLETED 
Condition: Colon Polyp 

NCTID: NCT02654418

Title: Safety Study of SIC 8000 in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger Than 2 cm 
Study Summary: SIC 8000 is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare. 
Sponsor: Cosmo Technologies Ltd 
Intervention: Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size) 
Start Date: 2016-02 
Last Updated: 2017-09-05 
Number of Patients: 226 
Recruitment Status: COMPLETED 
Condition: Adenomas 

NCTID: NCT05793489

Title: Prospective Double Arm Randomized Trial: WBRT Alone and WBRT Plus Silibinin 
Study Summary: The occurrence of brain metastases (BMs) is increasing given the availability of a more accurate radiological imaging such as MRI for detecting also small brain lesions and the most effective systemic therapy able to control extracranial disease. Although, the new target therapy and immunotherapy has proven to be effective on brain metastasis too, a subgroup of patients shows prove themselves unresponsive to medical treatment. A further subgroup of patients exhibit diffuse brain disease for the presence of multiple brain lesion (>10 BMs) or leptomeningeal carcinomatosis. Among these patients the most treatment employed is represented by whole brain RT. Since the 1950s, whole-brain radiation therapy (WBRT) has been the most widely used treatment for patients with multiple brain metastases, given its effectiveness in palliation, widespread availability, and ease to delivery. However, the median overall survival recorded is restricted to 3 months, on the average. A better understanding of the molecular and cellular mechanisms underlying brain metastasis might be expected to lead to improvements in the overall survival rate for these patients. Recent studies have revealed complex interactions between metastatic cancer cells and their microenvironment in the brain. Priego et al. describe that brain metastatic cells induce and maintain the co-option of a pro-metastatic program driven by signal transducer and activator of transcription 3 (STAT3) in a subpopulation of reactive astrocytes surrounding metastatic lesions. In patients, active STAT3 in reactive astrocytes correlates with reduced survival from diagnosis of intracranial metastases. Blocking STAT3 signaling in reactive astrocytes reduces experimental brain metastasis from different primary tumor sources, even at advanced stages of colonization. Silibinin (or silybin) is a natural polyphenolic flavonoid isolated from seed extracts of the herb milk thistle (Silybum marianum). Silibinin has been shown to impair STAT3 activation. Preclinical studies show that Silibinin has an anticancer effects in vitro and in vivo.  Based on this background, the investigators designed a double arm randomized trial evaluating the benefit of Silibinin (in the form of marketed supplement) associated to WBRT respect to WBRT alone. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Silibinin 
Start Date: 2023-03-06 
Last Updated: 2023-04-13 
Number of Patients: 44 
Recruitment Status: RECRUITING 
Condition: Brain Metastases, Adult 

NCTID: NCT03569241

Title: PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases 
Study Summary: A proportion of prostate cancer (PCa) patients develop relapse following curative local treatment. Regional nodal recurrence is an emerging clinical situation since the introduction of new molecular imaging methods in the restaging of recurrent prostate cancer. More specifically, a subgroup of these patients is being diagnosed with a recurrence confined to the regional lymph nodes and limited in number (oligorecurrence) using choline or PSMA PET-CT. As there are no specific treatment recommendations for these type of patients, different treatment approaches are currently used, mostly focusing on local ablative treatments using radiotherapy or surgery. These treatments are coined metastasisdirected therapy (MDT). MDT in combination with or without temporary ADT could delay the subsequent risk of progression, and even cure limited regional nodal recurrences. Consequently, lifelong palliative ADT, with its toxicity and excess in non-cancer mortality might be postponed.  The proposed trial randomizes patients with oligorecurrent nodal prostate cancer following primary PCa treatment to either metastasis-directed therapy (MDT) (salvage lymph node dissection, sLND or stereotactic body radiotherapy, SBRT) or MDT plus whole pelvis radiotherapy (WPRT: 45 Gy in 25 fractions). 
Sponsor: University Ghent 
Intervention: whole pelvic radiotherapy 
Start Date: 2018-04-27 
Last Updated: 2023-06-28 
Number of Patients: 196 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Prostate Cancer 

NCTID: NCT02056041

Title: Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma 
Study Summary: Selection criteria for safe hepatectomy for HCC are not well established. The aim of this study was the validation of the selection criteria for safe hepatectomy for hepatocellular carcinoma. 
Sponsor: University of Milan 
Intervention: Hepatectomy 
Start Date: 2004-01 
Last Updated: 2014-06-18 
Number of Patients: 336 
Recruitment Status: COMPLETED 
Condition: Hepatectomy 

NCTID: NCT05728632

Title: Cardioprotective Effects of Nebivolol Versus Placebo in Patients Undergoing Chemotherapy With Anthracyclines 
Study Summary: As the cancer-related prognosis improves thanks to recent advances in cancer-targeted therapies, the prognostic burden of chemotherapy-related complications - including cardiotoxicity - is increasingly recognised. So far, the evidence supporting pharmacological preventive strategies in cardio-oncology has been inconsistent and conflicting, and there is a clear need for well-designed trials with novel interventions. In this study, by using cardiac magnetic resonance, the investigators want to assess if a commonly used beta-blocker with a unique pharmacological profile, i.e. nebivolol, can prevent cardiac dysfunction in patients with breast cancer or diffuse large B-cell lymphoma undergoing chemotherapy with anthracyclines. 
Sponsor: Giulio Stefanini 
Intervention: Nebivolol 
Start Date: 2019-01-01 
Last Updated: 2023-02-23 
Number of Patients: 80 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT02820194

Title: A Trial on SBRT Versus MWA for Inoperable Colorectal Liver Metastases (CLM) 
Study Summary: The trial is designed to perform a rigorous evaluation of efficacy and tolerability of SBRT by means of a randomised, controlled trial in patients affected by inoperable colorectal liver metastases. The chosen comparator is MWA.  The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term outcomes. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Stereotactic Body Radiation Therapy 
Start Date: 2016-06 
Last Updated: 2022-09-16 
Number of Patients: 26 
Recruitment Status: TERMINATED 
Condition: Secondary Malignant Neoplasm of Liver 

NCTID: NCT04079478

Title: The AID Study: Artificial Intelligence for Colorectal Adenoma Detection 
Study Summary: Colonoscopy is clinically used as the gold standard for detection of colon cancer (CRC) and removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there exists a disappointing level of adenomas missed at colonoscopy. “Back-to-back” colonoscopies have indicated significant miss rates of 27% for small adenomas (< 5 mm) and 6% for adenomas of more than 10 mm in diameter. Studies performing both CT colonography and colonoscopy estimate that the colonoscopy miss rate for polyps over 10 mm in size may be as high as 12%. The clinical importance of missed lesions should be emphasized because these lesions may ultimately progress to CRC8.  Limitations in human visual perception and other human biases such as fatigue, distraction, level of alertness during examination increases such recognition errors and way of mitigating them may be the key to improve polyp detection and further reduction in mortality from CRC. In the past years, a number of CAD systems for detection of polyps from endoscopy images have been described. However, the benefits of traditional CAD technologies in colonoscopy appear to be contradictory, therefore they should be improved to be ultimately considered useful. Recent advances in artificial intelligence (AI), deep learning (DL), and computer vision have shown potential to assist polyp detection during colonoscopy. 
Sponsor: Istituto Clinico Humanitas 
Intervention: AI 
Start Date: 2019-09-25 
Last Updated: 2020-02-12 
Number of Patients: 700 
Recruitment Status: COMPLETED 
Condition: Colon Cancer 

NCTID: NCT04624828

Title: Immune Response Evaluation in Oligorecurrent and Oligoprogressive Prostate Cancer Patients Treated With SBRT 
Study Summary: At the moment there is a lack of data in the setting of oligometastatic PC in particular regarding the interaction between ablative SBRT, ADT and patient’s immune system response.  The hypothesis underlying this project consists in the idea that the patient’s immunological context, RT and ADT may interact in the context of metastatic PC. Indeed the immune landscape of patients may interfere with the efficacy of SBRT and on the other side RT may modulate the immune response by driving immunotolerance.  Scope of the study will be to investigate the immune modulation after SBRT in:  * patients with diagnosis of oligorecurrence during a treatment-free interval * patients with oligoprogression or oligopersistance during hormonal therapy 
Sponsor: Istituto Clinico Humanitas 
Intervention: Radiotherapy 
Start Date: 2020-10-19 
Last Updated: 2023-02-06 
Number of Patients: 40 
Recruitment Status: RECRUITING 
Condition: Oligorecurrent and Oligoprogressive Prostate Cancer Patients 

NCTID: NCT02848196

Title: An Image-guided SBRT for Adrenal Gland Metastasis in Oligometastatic Patients 
Study Summary: The study is designed to to assess the efficacy of ablative SBRT delivered with VMAT technique in oligometastatic patients affected by adrenal gland metastases. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Stereotactic Body Radiation Therapy 
Start Date: 2016-10-19 
Last Updated: 2022-05-04 
Number of Patients: 40 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Adrenal Gland Metastases 

NCTID: NCT04328844

Title: A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers 
Study Summary: The objective of study IOA-244-101 is to determine whether IOA-244 is safe and tolerable in cancer patients (Part A). In addition, the study will assess whether IOA-244 can increase the anti-tumour immune response in patients both as monotherapy and in combination pemetrexed/cisplatin/avelumab (Part B Mesothelioma and NSCLC 1st line), in combination with avelumab (Part B Cutaneous Melanoma and NSCLC 2nd/3rd line) and ruxolitinib (Part B Primary Myelofibrosis) 
Sponsor: iOnctura 
Intervention: IOA-244 
Start Date: 2020-02-25 
Last Updated: 2023-06-29 
Number of Patients: 210 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Solid Tumor, Adult 

NCTID: NCT05727176

Title: Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement 
Study Summary: This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements. 
Sponsor: Taiho Oncology, Inc. 
Intervention: TAS-120 
Start Date: 2023-05-12 
Last Updated: 2023-10-05 
Number of Patients: 120 
Recruitment Status: RECRUITING 
Condition: Advanced Cholangiocarcinoma 

NCTID: NCT04104776

Title: A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas 
Study Summary: First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2. 
Sponsor: Constellation Pharmaceuticals 
Intervention: CPI-0209 
Start Date: 2019-09-18 
Last Updated: 2023-11-02 
Number of Patients: 286 
Recruitment Status: RECRUITING 
Condition: Advanced Solid Tumor 

NCTID: NCT03756636

Title: “Underwater” Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis. 
Study Summary: All procedures are performed in the investigator’s outpatient gastroenterology and digestive endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower intestinal tract.  Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion the lumen will be completely decompressed with aspiration of the gas, and then again relaxed with the instillation of only water. The EleviewTM will be injected into the submucosa in such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic evidence of complete resection. All the removed material will be stored and sent to histological analysis. Tolerability score will be recorded during the procedure.  Any “bleeding” (both intra- and post-procedural), perforation, post-polypectomy syndrome, stenosis or death in the 6 months following the procedure will be born “complication”.  A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months after the procedure 
Sponsor: Istituto Clinico Humanitas 
Intervention: “Underwater” mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM) 
Start Date: 2018-06-01 
Last Updated: 2020-01-13 
Number of Patients: 40 
Recruitment Status: COMPLETED 
Condition: Colo-rectal Polyps 

NCTID: NCT05043857

Title: Stereotactic PAncreatic RadioTherapy Adjuvant Therapy 
Study Summary: While surgery is considered the only potentially curative therapy for pancreatic cancer, 5-year overall survival (OS) is typically <25%. Following surgical resection of pancreatic cancer, adjuvant conventionally fractionated RT (CRT, delivering 45-54 Gy in 1.8-2.0 Gy per fraction) with 5-FU chemotherapy is recommended in high-risk patients (positive lymph nodes and/or R1-R2 resection margin status). However, the benefit of CRT in this setting is controversial due to lack of prospective positive data. Moreover, duration of treatment course (delaying initiation of more effective chemotherapy schedules), insufficient dose delivery due potential radiation-related severe toxicity to proximity organs represents a serious limitation to treatment efficacy. Stereotactic Body Radiotherapy (SBRT) is a novel radiotherapy technique consisting of highly focused irradiation with a steep dose gradient, thus allowing the delivery of ablative radiation doses and significant sparing of proximity critical structures. Higher doses per fraction allows for more intensive treatments and shorter duration of the radiation course. 
Sponsor: Istituto Clinico Humanitas 
Intervention: Stereotactic Body Radiotherapy (SBRT) 
Start Date: 2021-07-06 
Last Updated: 2022-09-16 
Number of Patients: 50 
Recruitment Status: RECRUITING 
Condition: Pancreas Cancer 

NCTID: NCT02263144

Title: Resect and Discard Extension to FICE of NIcE Classification 
Study Summary: The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color Enhancement (FICE) technology with high-definition without optical magnification. 
Sponsor: Istituto Clinico Humanitas 
Intervention: virtual chromo-endoscopy using FICE Fujifilm Technology 
Start Date: 2014-05 
Last Updated: 2014-10-13 
Number of Patients: 110 
Recruitment Status: UNKNOWN 
Condition: Hyperplastic Polyps 

NCTID: NCT03516981

Title: A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) 
Study Summary: This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile <math display="block">GEP</math> and tumor mutational burden <math display="block">TMB</math>) will be randomized to receive pembrolizumab in combination with quavonlimab (MK-1308), favezelimab (MK-4280), or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either quavonlimab, favezelimab, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2018-10-01 
Last Updated: 2022-08-26 
Number of Patients: 318 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced Non-Small Cell Lung Cancer 

NCTID: NCT03302234

Title: Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598) 
Study Summary: The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.  With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2017-12-14 
Last Updated: 2023-09-26 
Number of Patients: 568 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT04380636

Title: Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) 
Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:  # Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) # Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2020-07-06 
Last Updated: 2023-11-07 
Number of Patients: 870 
Recruitment Status: RECRUITING 
Condition: Lung Neoplasms 

NCTID: NCT05338970

Title: HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy 
Study Summary: Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC. 
Sponsor: Daiichi Sankyo, Inc. 
Intervention: Patritumab Deruxtecan 
Start Date: 2022-05-10 
Last Updated: 2023-11-18 
Number of Patients: 560 
Recruitment Status: RECRUITING 
Condition: Nonsquamous Non-small Cell Lung Cancer

hasCancerType::C00-D48: All neoplasms hasCancerType::C00-C97: All cancer types hasCancerType::C00-C14: Mouth/throat cancers hasCancerType::C15-C26: Digestive system cancers hasCancerType::C30-C39: Lung/chest cancers hasCancerType::C40-C41: Bone cancers hasCancerType::C43-C44: Skin cancers/melanoma hasCancerType::C45-C49: Soft tissue cancer hasCancerType::C50: Breast cancer hasCancerType::C51-C58: Female genitalia cancers hasCancerType::C60-C63: Male genitalia cancer hasCancerType::C64-C68: Urinary system cancers hasCancerType::C69-C72: Eye and brain cancer hasCancerType::C73-C75: Thyroid and other gland cancers hasCancerType::C76-C80: Cancers of unknown or unspecified areas hasCancerType::C81-C96: Cancers of the blood and immune system hasCancerType::C97-C97: Cancers in multiple locations from the start hasCancerType::D00-D09: Early-stage cancers not yet spread hasCancerType::D10-D36: Benign tumour hasCancerType::D37-D48: Growths of uncertain nature hasCancerType::unknown isTrial