Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06819566

PHASE2

Prophylactic Endoscopic Variceal Ligation in Patients With High-risk Esophageal Varices Receiving Atezo/Bev for HCC

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

Summary

The goal of this study is to evaluate whether prophylactic endoscopic variceal ligation (EVL) can prevent esophageal variceal bleeding in patients with hepatocellular carcinoma (HCC) receiving atezolizumab and bevacizumab (Atezo/Bev) therapy. The study will also assess the safety of prophylactic EVL in this population. The main question it aims to answer is: Does prophylactic EVL in high-risk varices reduce the incidence of variceal bleeding to a level similar to that of low-risk varices in HCC patients receiving Atezo/Bev? Participants will: 1. Undergo prophylactic EVL before starting Atezo/Bev therapy (within 2 weeks ± 1 week before the first dose). 2. Start Atezo/Bev therapy 2 weeks (± 1 week) after EVL. 3. Have follow-up endoscopies (EGD) one week after the 3rd, 5th, and 7th doses of Atezo/Bev. If varices improve, no additional intervention is needed. If varices persist or worsen, on-demand EVL will be performed, and Atezo/Bev will continue. This study will help determine if prophylactic EVL should be a standard strategy for managing high-risk varices in HCC patients undergoing Atezo/Bev therapy.

Official title: Prophylactic Endoscopic Variceal Ligation in Patients With High-risk Esophageal Varices Receiving Atezolizumab Plus Bevacizumab for Hepatocellular Carcinoma : A Phase II, Multicenter, Single-arm Trial (ESCOAT Trial)

Key Details

Gender

All

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-28

Completion Date

2029-03-31

Last Updated

2025-07-24

Healthy Volunteers

Conditions

Hepatocellular Carcinoma Esophageal Varix Bleeding Esophageal Varices

Interventions

PROCEDURE

Endoscopic variceal ligation (EVL)

1. EVL for high-risk varices will be performed by experienced endoscopists, certified in gastroenterological endoscopy, within two weeks prior to the initiation of the Atezo/Bev. 2. A follow-up EGD will be conducted one week after the Atezo/Bev #3. If any of the following criteria are met, additional EVL will not be performed, and anticancer treatment will proceed two weeks later. Otherwise, an additional on-demand EVL session will be conducted: * The esophageal varices have improved to F1 or less. * The red color sign has disappeared. 3. On-demand EVL will be considered after 5th, and 7th consecutive doses of Atezo/Bev, with EGD follow-up performed to assess eligibility. The maximum number of EVL sessions is limited to three sessions.

Inclusion Criteria: * Patients aged 19 years or older and under 80 years. * Patients with liver function are classified as Child-Pugh Class A. * Barcelona Clinic Liver Cancer stage C patients with no prior systemic anticancer therapy for hepatocellular carcinoma. * Patients with an Eastern Cooperative Oncology Group performance score of 0-1. * Adequate Hematologic and Liver Function: A. Hemoglobin: ≥ 9.0 g/dL B. Absolute Neutrophil Count : ≥ 1,000/mm³ C. Platelet Count: ≥ 70,000/μL D. Prothrombin Time: ≥ 70% (or Prothrombin Time INR ≤ 1.2) * Patients with upper gastrointestinal endoscopy performed within six months prior to the start of anticancer treatment. * No plans for breastfeeding, and if of childbearing potential, using contraception or no plans for spouse's pregnancy or practicing contraception. * Patients who have received an explanation of the treatment purpose and methods and have provided informed consent for the treatment. Exclusion Criteria: * Participants who have previously received systemic anticancer therapy for advanced hepatocellular carcinoma. * Patients with intrahepatic tumor involvement of 50% or more. * Patients with tumor thrombus in the main portal vein or both first-order branches (Vp4). * Patients with a prior history of liver transplantation. * with uncontrolled malignant tumors other than HCC at the time of enrollment (participation is allowed if disease-free survival exceeds two years). * Patients with uncontrolled or serious underlying diseases requiring treatment. * Patients with a history of esophageal or gastric variceal bleeding. * Previous Variceal Treatments: Patients who have undergone any of the following treatments for variceal bleeding: A. Endoscopic Variceal Obliteration (EVO) B. EVL C. Transjugular Intrahepatic Portosystemic Shunt (TIPS) D. Percutaneous Approach for Retrograde Transvenous Obliteration (PARTO) E. Surgical procedures * Patients who have used anticoagulants or antiplatelet agents within one week prior to the study. * Presence of grade 2 or higher isolated gastric varices or Red Color Signs confirmed by baseline endoscopy (EGD). * Patients who are pregnant. * Patients who are unable to understand or provide written informed consent. * Patients deemed unsuitable for clinical study participation based on the investigator's judgment.

Locations (1)

Liver cancer center, Asan Medical Center

Seoul, Song-pa, South Korea