Randomized Study of TACE with Sintilimab, Bevacizumab, and Ipilimumab N01 for Treating Advanced Liver Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early effectiveness of a combination treatment involving Transarterial Chemoembolization TACE, sintilimab, bevacizumab, and ipilimumab N01 in adults with advanced hepatocellular carcinoma HCC. The study aims to determine how safe and effective this combination is and to explore how different timing schedules of ipilimumab N01 affect outcomes. It also investigates biomarkers that might predict treatment responses. Participants are randomly assigned to one of three treatment groups Group A receives TACE, sintilimab, bevacizumab, and a single dose of ipilimumab N01 three weeks after the first dose of sintilimab and bevacizumab Group B receives TACE, sintilimab, bevacizumab, and a single dose of ipilimumab N01 concurrently with the first dose of sintilimab and bevacizumab Group C receives TACE, sintilimab, and bevacizumab without ipilimumab N01. Treatments are given intravenously every three weeks, with TACE performed as part of the therapy. During the study, participants undergo regular clinic visits for safety checks and tumor imaging every six weeks initially, then every twelve weeks after 48 weeks. Biological samples such as blood and tumor biopsies are collected at baseline and during treatment for biomarker analysis. A safety follow-up occurs 30 days after the last dose, and survival follow-up contacts happen every 90 days to monitor survival status and subsequent treatments. The study continues until disease progression, intolerable side effects, or withdrawal.

A Prospective, Randomized Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 Treating Advanced HCC