Randomized Phase 2 Study of Yttrium 90Y Microsphere Injection with Camrelizumab andor Apatinib Compared to cTACE for Treating Unresectable Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating treatments for people with hepatocellular carcinoma HCC that cannot be removed by surgery or treated with ablation and has not spread to other parts of the body. This Phase 2 study compares the effects and safety of yttrium 90Y microsphere injection combined with immunotherapy drugs camrelizumab andor apatinib, versus yttrium 90Y microsphere injection alone and the conventional transcatheter arterial chemoembolization cTACE procedure. The goal is to find out how well these treatments work and their safety profiles in this patient group. Participants will be randomly assigned to one of four groups yttrium 90Y microsphere injection plus camrelizumab and apatinib yttrium 90Y microsphere injection plus camrelizumab yttrium 90Y microsphere injection alone or cTACE. Yttrium 90Y microspheres are delivered through the hepatic artery based on a mapping procedure, while camrelizumab is given every three weeks starting shortly after randomization. Apatinib treatment begins after the first cycle and is paused around the yttrium 90Y injection. Treatments continue until withdrawal criteria are met, with yttrium 90Y and immunotherapies given for up to 18 months. During the study, participants will undergo regular assessments including imaging to measure tumor response and progression-free survival up to 18 months. Safety, overall survival, and other measures such as duration of response and disease control rate are also evaluated. The study involves multiple visits for treatment, monitoring, and follow-up to track how participants respond and to observe any side effects over time.

A Study of Yttrium [90Y] Microsphere Injection in Combination With Targeted Immunotherapy in the Treatment of HCC