Multicenter phase 2 trial of anlotinib plus toripalimab as first-line therapy for unresectable hepatocellular carcinoma

For patients with unresectable hepatocellular carcinome (uHCC), the first-line options are limited and treatment outcomes are poor. The multicenter phase 2 ALTER-H-003 trial in China evaluated the combination of anlotinib (TKI) and toripalimab (anti-PD-1) for previously untreated, unresectable hepatocellular carcinoma. The combination had promising activity and manageable safety. The median progression-free survival was 11.0 months and the median overall survival was 18.2 months.