Adaptive Phase II Trial Testing Personalized Second-Line Therapies for Advanced Hepatocellular Carcinoma Using Biomarker Guidance

What this Trial Is About

Researchers are investigating new treatments for advanced hepatocellular carcinoma HCC in patients whose first-line therapies have not been successful. This phase II adaptive platform trial aims to quickly identify the most effective second-line treatment options and discover biomarkers from tumor tissue, blood, and imaging that can help personalize therapy. The study uses a Bayesian design to adjust treatments based on ongoing results, optimizing therapy choices for participants with advanced liver cancer. Participants will be randomly assigned to one of several treatment groups. These include drugs such as Lenvatinib or Regorafenib alone, combinations of Tislelizumab with tyrosine kinase inhibitors TKIs, hepatic arterial infusion chemotherapy HAIC with or without additional immunotherapy agents like Tislelizumab, QL1706, or Camrelizumab, and chemotherapy regimens combined with these drugs. Treatments involve oral medications and intravenous infusions given in cycles, with some repeated every 3 weeks for up to 4 cycles. The study allows dropping less effective treatments and adding new ones as the trial progresses. During the study, participants will undergo tumor assessments using imaging and biomarker tests from tissue and blood samples to monitor response. Researchers will evaluate outcomes such as objective response rate, disease control, duration and time to response, progression-free survival, overall survival, and treatment-related side effects. The trial includes regular visits and assessments for up to 42 months, with ongoing safety monitoring and data collection to better understand which therapies work best for different patient groups.

A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma