Phase 2 Study of TAEHAIC with Camrelizumab and Apatinib for Advanced Liver Cancer with High Tumor Load

What this Trial Is About

Researchers are evaluating a combination treatment involving TAE transarterial embolization, HAIC hepatic arterial infusion chemotherapy, camrelizumab, and apatinib for advanced liver cancer with a high tumor burden. This phase 2, single-arm, prospective, multicenter study aims to explore the safety and effectiveness of this new regimen in patients with advanced hepatocellular carcinoma. The study is designed to provide important data for future larger clinical trials and to identify a potential new treatment approach for this condition. The treatment involves arterial infusion of TAE and HAIC combined with intravenous camrelizumab and oral apatinib. Camrelizumab is given intravenously at 200 mg every three weeks, starting one day before arterial infusion treatments. The TAE and HAIC treatments consist of iodized oil and chemotherapy drugs infused into the liver arteries on the second day of each cycle. Oral apatinib is taken daily after discharge, with a pause for three days before the next cycle. This regimen is given in cycles, and the study focuses on patients with a high tumor load. Participants will be monitored through various assessments including imaging scans to measure tumor response, blood tests to evaluate organ function, and questionnaires to track side effects. The primary outcome is the objective response rate at one year. Secondary outcomes include disease control rate, progression-free survival, tumor progression time, overall survival over three years, and adverse events. Participants are expected to be followed for safety and efficacy throughout the study period, with careful evaluation of liver function and tumor status.

A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma