Phase III Study of Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy as First Treatment for Advanced Hepatocellular Carcinoma

What this Trial Is About

Researchers are evaluating the use of Camrelizumab and Apatinib, with or without intravenous FOLFOX chemotherapy, as a first-line treatment for advanced hepatocellular carcinoma HCC, a type of liver cancer. This phase III multicenter randomized study aims to compare these treatment approaches in patients whose cancer is advanced and unsuitable for surgery or local therapies, or who have progressed after such treatments. The study includes two treatment groups one receiving a combination of infusional mFOLFOX7 chemotherapy plus Camrelizumab and Apatinib, and the other receiving Camrelizumab and Apatinib alone. The chemotherapy regimen involves specific doses of oxaliplatin and fluorouracil administered in cycles, while Camrelizumab is given by infusion every 21 days and Apatinib is taken orally daily. Chemotherapy is given for up to six cycles, and treatments continue in 21-day cycles. Participants will be monitored over several years for outcomes including progression-free survival and overall survival, with assessments up to approximately three to five years. Various secondary outcomes related to tumor response, disease control, and safety are also tracked. The study involves regular imaging scans, laboratory tests, and clinical evaluations to measure treatment effects and side effects. Participation may last for multiple years, including follow-up periods to assess long-term outcomes and safety.

Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC