Phase 2 trial of first-line hepatic artery infusion chemotherapy with serplulimab and HLX04 for advanced hepatocellular carcinoma

A phase 2 trial at Tianjin (China) Medical University evaluated FOLFOX hepatic artery infusion in combination with serplulimab (anti-PD-1) and the bevacizumab biosimilar HLX04 for patients with previously untreated advanced hepatocellular carcinoma. Primary endpoint was objective response rate. Objective response was seen in 53.1% of patients, with stable disease in 37.5% additional patients, for a disease control rate of 90.6%. Progression-free survival rate was 89.9% at 6 months and 70.8% at 12 months. There were no grade 5 AEs; grade 4 and grade 3 AEs were seen in 12.5% and 37.5% of patients, respectively. The authors conclude that the first-line combination of FOLFOX HAIC with serplulimab and HLX04 for aHCC had promising efficacy and acceptable safety