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

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.

NCT Number	NCT06819566
Lead Sponsor	Asan Medical Center Collaborators: Seoul National University Hospital, Hanyang University, Samsung Medical Center, National Cancer Center, Korea, Seoul National University Bundang Hospital
Conditions	Hepatocellular Carcinoma, Esophageal Varix, Bleeding Esophageal Varices
Enrollment	44 participants
Start Date	2025-05-28
Primary Completion	2026-12-31 (estimated)
Study Completion	2029-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-24