Multinational phase 3 trial of first-line camrelizumab plus rivoceranib versus sorafenib for unresectable/metastatic HCC: final analysis of CARES-310

The phase 3 CARES-310 trial, at 95 centers in 13 counties, evaluated first-line camrelizumab (anti-PD-1) plus rivoceranib (VEGFR2 inhibitor) versus sorafenib in patients with unresectable or metastatic hepatocellular carcinoma (U/M HCC). Final analysis after median follow-up of 22.1 months has now been published. Median overall survival was 23.8 months with camrelizumab-rivoceranib and 15.2 months with sorafenib (HR 0.84; p<0.0001). Median progression-free survival was 5.6 months with camrelizumab-rivoceranib and 3.7 months with sorafenib (HR 0.54; pxtagstartz0.001). The most common grade 3 or 4 treatment-related adverse events were hypertension (38% versus 15%), palmar-plantar erythrodysesthesia syndrome (12% versus 16%), increased aspartate aminotransferase (17% versus 5%), and increased alanine aminotransferase (14% versus 3%). Treatment-related deaths occurred in one patient each in both groups. The authors conclude that first-line camrelizumab plus rivoceranib continued to show survival benefit compared with sorafenib, with manageable safety.