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

PHASE2RecruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

May 28, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

March 31, 2029

Conditions
Hepatocellular CarcinomaEsophageal VarixBleeding 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."

Trial Locations (1)

05505

RECRUITING

Liver cancer center, Asan Medical Center, Seoul

Sponsors
All Listed Sponsors
collaborator

Seoul National University Hospital

OTHER

collaborator

Hanyang University

OTHER

collaborator

Samsung Medical Center

OTHER

collaborator

National Cancer Center, Korea

OTHER_GOV

collaborator

Seoul National University Bundang Hospital

OTHER

lead

Asan Medical Center

OTHER

NCT06819566 - Prophylactic Endoscopic Variceal Ligation in Patients With High-risk Esophageal Varices Receiving Atezo/Bev for HCC | Biotech Hunter | Biotech Hunter