Phase 2 Study of Cabozantinib with Ipilimumab, Nivolumab, and TACE in Adults with Hepatocellular Carcinoma Not Suitable for Curative Treatment

What this Trial Is About

This trial studies adults with hepatocellular carcinoma HCC who are not eligible for curative treatments like surgery or transplantation. It evaluates the effectiveness of combining cabozantinib with immune therapies ipilimumab and nivolumab, alongside transarterial chemoembolization TACE, a procedure targeting liver tumors. This is a phase 2, single-group, open-label study designed to observe how well this combination works in this patient group. Participants receive cabozantinib orally daily in 28-day cycles starting 7 to 14 days after their last TACE treatment. Nivolumab and ipilimumab are given intravenously in specific doses and schedules beginning after TACE. TACE procedures are performed up to three times within 9 to 12 weeks, with timing decided by the doctor. The study involves one treatment arm where all receive this combination. During the study, participants undergo regular assessments including scans and lab tests to monitor tumor response and side effects. Researchers measure progression-free survival at six months and complete response rates up to about one year. Secondary outcomes include overall survival, adverse event rates, and ability to convert tumors to resectable status. Participants are monitored closely during treatment and follow-up, with the study lasting until around September 2027.

Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma