Transarterial Chemoembolization Combined With Camrelizumab and Rivoceranib for Unresectable Hepatocellular Carcinoma (CHANCE2005/CARES-005): A Randomized Phase II Trial

Clinical Snapshot

Key Findings

• P Value: P < 0.001

• Effect Size: Hazard ratio 0.34 (66% reduction in progression risk)

• Primary Outcome: Median progression-free survival per composite criteria: 10.8 months (TACE-C-R) vs 3.2 months (TACE alone)

• Nnt Or Sensitivity: Number needed to treat approximately 2 patients to prevent one progression event over median follow-up period

• Confidence Interval: 95% CI: 0.24 to 0.50

Clinical Application

Requires access to interventional radiology services for TACE and oncology support for immunotherapy/targeted therapy combination Camrelizumab not currently PBS-listed in Australia. Rivoceranib availability limited. Would require special access scheme or clinical trial participation for Australian patients Australian patients with unresectable HCC, Child-Pugh A liver function, BCLC stage A-C without extrahepatic metastases

Abstract

PURPOSE: Transarterial chemoembolization (TACE) alone has shown limited efficacy in improving survival among patients with unresectable hepatocellular carcinoma (HCC). This phase II trial compared TACE combined with camrelizumab (anti-PD-1 antibody) and rivoceranib (vascular endothelial growth factor receptor 2 inhibitor) versus TACE in unresectable HCC. METHODS: Patients with unresectable HCC (Barcelona Clinic Liver Cancer stage A to C without extrahepatic metastases) and Child-Pugh class A liver function were randomly assigned (1:1), stratified by macrovascular invasion, previous tyrosine kinase inhibitor treatment, and number of previous TACE procedures, to receive TACE combined with camrelizumab (200 mg once every 3 weeks) and rivoceranib (250 mg once daily; TACE-C-R) or TACE alone. The primary end point was progression-free survival (PFS) per composite criteria (progression per 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. RESULTS: Between December 28, 2020, and October 29, 2023, 200 patients were randomly assigned (100 in each group). Median PFS per composite criteria was significantly longer with TACE-C-R than with TACE (10.8 months [95% CI, 8.8 to 13.7] v 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 treatment-related adverse events occurred in 74.5% (70 of 94) of patients with TACE-C-R and 22.3% (23 of 103) of patients with TACE, with the most common being increased AST (29 [30.9%] and 13 [12.6%]) and increased ALT (23 [24.5%] and 14 [13.6%]). CONCLUSION: The addition of camrelizumab and rivoceranib to TACE showed statistically significant improvement in PFS for patients with unresectable HCC, with a manageable safety profile. Follow-up for further overall survival analysis is ongoing.

References

1. 1.Zhu, H. D., Fan, W. J., Zhao, C., Wang, S., Li, Y. L., Jin, Z. C., Zhang, Z. W., Guo, J. H., Cheng, H. T., Zhang, Q., Lu, J., Zeng, Y. Y., Lv, W. F., Xu, H., Shao, H. B., Xu, W. G., Zhao, X. Y., Gu, S. Z., Lin, H. L., Zheng, W. H., Piao, L. Z., Song, Y. S., Zhao, J. B., Wang, Y. C., Hou, Z. G., Sun, Y., Guan, N., Huang, M., Yang, W. Z., Ji, J. S., & Teng, G. J. (2026). Transarterial chemoembolization combined with camrelizumab and rivoceranib for unresectable hepatocellular carcinoma (CHANCE2005/CARES-005): A randomized phase II trial. Journal of Clinical Oncology. https://doi.org/10.1200/JCO-25-01796