Study of VRT106 Combined With Camrelizumab and Apatinib for Advanced Liver Cancer After Immune Checkpoint Inhibitor Failure

What this Trial Is About

This research investigates treatments for patients with advanced hepatocellular carcinoma HCC who have not responded to prior immune checkpoint inhibitors ICIs. It is an open-label phase IIIII clinical trial aiming to assess the safety, effectiveness, and appropriate dosing of the drug VRT106 in combination with camrelizumab and apatinib. The study includes dose-escalation and dose-expansion stages, with a phase III portion planned based on data gathered from phase II. The trial involves three treatment groups VRT106 alone given by intravenous infusion, VRT106 combined with camrelizumab intravenous infusion and apatinib oral administration, and a group receiving the investigators choice of standard care. Phase II Part A focuses on determining a recommended dose by evaluating safety and tolerability. Part B compares progression-free survival between the combination treatment and standard care. The phase III segment will assess overall survival between these treatments. Participants will be monitored through assessments including dose-limiting toxicities within 56 days of starting VRT106, as well as progression-free and overall survival over about two years. Eligibility includes adults aged 18 to 75 with confirmed advanced HCC and good performance status. The study involves regular clinical evaluations and treatment administration according to assigned groups, with safety and effectiveness data collected throughout the trial period.

A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC