According to results from the phase 2 CAP-ACE study, adding camrelizumab, an anti-PD-1 monoclonal antibody, and apatinib, a tyrosine kinase inhibitor (TKI), to transarterial chemoembolization (TACE) significantly prolonged the progression-free survival (PFS) among patients with unresectable hepatocellular carcinoma eligible for embolization.

These results were first presented by Gao-Jun Teng, MD, Zhongda Hospital, Jiangsu, China, at the 2025 American Society for Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.

Dr Teng et al explained, “Combining immunotherapy and tyrosine kinase inhibitors with TACE can potentially enhance antitumor activity by activating the immune system and inhibiting tumor neovascularization.”

This open-label phase 2 study enrolled 200 patients with unresectable hepatocellular carcinoma who were eligible for embolization and had not previously received immunotherapy. Patients were randomized on a 1-to-1 basis to receive TACE either alone (n = 100), or in combination with camrelizumab and apatinib (n = 100). Randomization was stratified by vascular invasion, prior use of TKIs, and the number of prior TACE. The primary end point was PFS in the intention-to-treat population.

The median follow-up duration was 13.6 months. The median PFS was 11.0 months in the camrelizumab-apatinib plus TACE arm vs 3.1 months in the TACE alone arm, representing a statistically significant improvement (hazard ratio [HR], 0.3, P < .0001). The objective response rates were 65% and 30%, respectively. The disease control rates were 87.0% and 63%. Grade ≥3 treatment-related adverse events occurred in 76.6% of patients in the camrelizumab-apatinib plus TACE arm vs 24.3% in the TACE alone arm. Overall safety data was immature at the time of analysis.

The most common grade ≥3 treatment-related adverse events in the camrelizumab-apatinib plus TACE arm were increased AST, increased ALT, hypertension, and decreased platelet count. The most common grade ≥3 treatment-related adverse events in the TACE alone arm were increased ALT and increase AST.

Dr Teng et al concluded, “The addition of camrelizumab and apatinib to TACE can significantly prolong progression-free survival in patients with unresectable [hepatocellular carcinoma] eligible for embolization, with a manageable safety profile.

Source:

Zhu H, Teng G-J, Fan W, et al. Transarterial chemoembolization (TACE) combined with camrelizumab and apatinib versus TACE alone in the treatment of unresectable hepatocellular carcinoma eligible for embolization: A multicenter, open-label, randomized, phase 2 study (CAP-ACE). Presented at 2025 ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025; San Francisco, CA. Abstract LBA 522.