Multicenter randomized phase 2 trial of transarterial chemoembolization plus camrelizumab and rivoceranib for unresectable HCC

Transarterial chemoembolization (TACE) alone has shown limited efficacy for unresectable hepatocellular carcinoma (uHCC). The multicenter randomized phase 2 CHANCE2005/CARES-005 trial in evaluated addition of camrelizumab (C; anti-PD-1) and rivoceranib (R; VEGFR2 inhibitor) to TACE. Patients with uHCC without extrahepatic metastases and Child-Pugh class A liver fundtion were randomized (stratified by macrovascular invasion, previous TKI treatment, and number of previous TACE procedures) 1:1 to TACE-C-R (n=100) or TACE alone (n=100). The primary endpoint was progression-free survival (PFS) per compites criteria (progression per Response Evaluation Criteria in Cancer of the Liver version 5, deterioration to Child-Pugh class C, or TCE failure or refractoriness). Median PFS per composite criteria was significantly longer with TACE-C-R than with TACE alone (10.8 months versus 3.2 months; HR 0.34; p<0.001). Grade ≥ 3 treatment-related adverse events occurred in 74.5% of patients with TACE-CR versus 22.2% of patients with TACE alone. The authors conclude that addition of C-R to TACE resulted in significant improvement of PFS among patients with uHCC, with manageable safety. Follow-up for overall survival is ungoing.