TACE plus camrelizumab and rivoceranib prolongs progression-free survival versus TACE alone in unresectable HCC

This phase II trial randomly assigned 200 patients with unresectable hepatocellular carcinoma (HCC) 1:1 to TACE combined with camrelizumab (anti-PD-1; 200 mg every 3 weeks) and rivoceranib (VEGFR2 inhibitor; 250 mg once daily), or TACE alone. Eligible patients had Barcelona Clinic Liver Cancer stage A to C without extrahepatic metastases and Child-Pugh class A liver function. Randomization was stratified by macrovascular invasion, previous tyrosine kinase inhibitor treatment, and number of previous TACE procedures. Enrollment occurred between December 28, 2020, and October 29, 2023.

The primary end point was progression-free survival (PFS) per composite criteria—progression by Response Evaluation Criteria in Cancer of the Liver version 5, transient deterioration to Child-Pugh class C, or TACE failure or refractoriness—in the intention-to-treat population. Median PFS was significantly longer with TACE-C-R than with TACE alone: 10.8 months (95% CI, 8.8 to 13.7) versus 3.2 months (95% CI, 2.4 to 4.2); hazard ratio, 0.34 (95% CI, 0.24 to 0.50), P < .001.

Grade 3 or higher treatment-related adverse events occurred in 74.5% (70 of 94) of patients with TACE-C-R versus 22.3% (23 of 103) with TACE. The most common were increased AST (30.9% vs 12.6%) and increased ALT (24.5% vs 13.6%). The investigators described the safety profile as manageable. Specific serious adverse events, discontinuation rates, and dose-modification details were not reported in the abstract.

Limitations include the phase II design and the composite nature of the primary end point, which incorporates liver-function deterioration and TACE failure in addition to radiologic progression. Overall survival data are not yet mature; follow-up for further OS analysis is ongoing. Funding sources, conflicts of interest, study sites, and specific follow-up duration were not reported in the abstract.

Clinically, these phase II data suggest a meaningful PFS benefit from adding camrelizumab plus rivoceranib to TACE in unresectable HCC, offset by a substantial rise in grade 3+ toxicity—especially hepatic enzyme elevations. OS confirmation and real-world tolerability will be important before broad adoption.