Phase II Study of PD-L1 Antibody with Bevacizumab and Hepatic Arterial Infusion Chemotherapy for Advanced Unresectable Liver Cancer with Spread Outside the Liver

What this Trial Is About

Researchers are evaluating a combination treatment for patients with advanced hepatocellular carcinoma HCC who have cancer spread outside the liver and cannot have surgery. This phase II trial focuses on safety and effectiveness of a PD-L1 antibody combined with bevacizumab and hepatic arterial infusion chemotherapy HAIC. The study aims to improve outcomes for these patients, who currently have limited treatment options. Participants will receive intravenous PD-L1 antibody at 1200 mg and bevacizumab at 15 mgkg every three weeks. They will also undergo up to six cycles of HAIC-FOLFOX chemotherapy, which includes oxaliplatin, leucovorin, and fluorouracil delivered via hepatic artery infusion. After completing HAIC, treatment with PD-L1 antibody and bevacizumab continues until the disease progresses, unacceptable side effects occur, or up to 24 months. During the study, tumor assessments will be done every nine weeks for the first 48 weeks, then every 12 weeks thereafter. Safety, disease response, progression, survival, and quality of life will be monitored. The primary measure is the objective response rate, while secondary measures include disease control, duration of response, progression-free survival, overall survival, and safety. The study plans to enroll 36 patients from October 2024 through July 2027.

PD-L1 Antibody + Bevacizumab With Hepatic Arterial Infusion Chemotherapy for Advanced HCC