Camrelizumab Plus Rivoceranib/TACE Improve PFS, Increases Toxicity in uHCC

Camrelizumab plus rivoceranib and transarterial chemoembolization (TACE) improved progression-free survival (PFS), overall response rate (ORR), and exhibited a favorable overall survival trend (OS) as a treatment for patients with unresectable hepatocellular carcinoma (HCC) eligible for TACE. These results from a multicenter, randomized phase 3 trial (NCT05320692) were shared at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

The median PFS, which was statistically significant and clinically meaningful, when assessed by blinded independent review committee (BIRC) per modified RECIST criteria, was 11.1 months (95% CI, 7.8-14.0) in patients who received camrelizumab plus rivoceranib and TACE compared with 8.3 months (95% CI, 6.9-9.5) in patients who received TACE alone (HR, 0.73; 95% CI, 0.56-0.96; P = .0127); when assessed by investigators, the median PFS was 13.8 months (95% CI, 8.5-17.3) vs 7.0 months (95% CI, 5.7-9.5), respectively (HR, 0.61; 95% CI, 0.47-0.81).

Using RECIST v1.1 criteria, when PFS was assessed by BIRC, the median values were 13.9 months (95% CI, 10.9-19.4) vs 9.5 months (95% CI, 8.1-11.1), respectively (HR, 0.67; 95% CI, 0.50-0.91); when PFS was assessed by the investigator, the median values were 15.7 months (95% CI, 10.3-19.6) vs 8.4 months (95% CI, 6.9-10.8), respectively (HR, 0.61; 95% CI, 0.45-0.81).

Though OS data were not fully mature at the time of analysis, with 31 events and 36 events in the investigational and control arms, respectively, a benefit in favor of camrelizumab plus rivoceranib and TACE was observed (HR, 0.76; 95% CI, 0.46-1.24). The 12-month OS rate was 91.4% (95% CI, 86.1%-94.8%) with the camrelizumab regimen vs 85.5% (95% CI, 78.8%-90.1%) with TACE alone, and the 24-month OS rate was 82.0% (95% CI, 74.0%-87.7%) vs 73.3% (95% CI, 64.0%-80.5%).

Tumor responses were assessed by BIRC using modified RECIST criteria. The ORR was 60.3% (95% CI, 53.4%-66.9%) with the investigational regimen vs 45.5% (95% CI, 38.6%-52.5%) with TACE alone, for a between group difference of 14.8% (95% CI, 5.4%-24.2%). The disease control rate was 85.5% (95% CI, 80.1%-89.9%) vs 74.6% (95% CI, 68.2%-80.4%), respectively, and the median duration of response (DOR) was 16.6 months (95% CI, 10.9-20.7) vs 8.2 months (95% CI, 7.0-13.8).

Across the experimental and control arms, complete responses (CRs) were noted in 5.6% vs 3.8%, respectively; partial responses were observed in 54.7% vs 41.6%, stable disease in 25.2% vs 29.2%, and progressive disease in 6.5% vs 15.3%.

“TACE is the guideline-recommended standard of care for intermediate-stage HCC, and camrelizumab plus rivoceranib with TACE provided a statistically significant and clinically meaningful improvement in PFS vs TACE, with manageable safety,” said presenting author Tao Peng, MD, of the Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangxi Medical University, in Nanning, China, during the presentation.

A total of 423 patients were randomly assigned 1:1, with 214 being assigned to the experimental arm and 209 to the control arm. Across both arms, only 1 patient in the experimental arm did not receive the assigned treatment. Camrelizumab was given at 200 mg every 3 weeks and oral rivoceranib at 250 mg daily. Treatment with TACE was either conventional TACE or TACE with drug-eluting beats, administered at the investigator’s discretion.

Eligible patients for the trial were 18 years or older with confirmed HCC not amenable to curative treatment, but who were eligible for TACE and had not received prior systemic anti-cancer therapy. They also had an ECOG performance status of 0 or 1, Child-Pugh class A liver function, no extrahepatic spread, and no macrovascular invasion.

The primary end point of the trial was PFS by BIRC per modified RECIST criteria. Secondary end points included OS, PFS by BIRC per RECIST v1.1, ORR, DCR, DOR, and safety.

Regarding safety, 98.1% of patients in the investigational arm experienced any-grade treatment-related adverse events vs 90.0% in the TACE arm. Notably, grade 3 or higher TRAEs occurred in 73.7% vs 28.7%, and serious TRAEs in 31.0% vs 4.3%.

TRAEs led to death and discontinuation of any study intervention in 1.4% and 22.1% of patients in the investigational arm; no patients in the TACE alone arm experienced death or treatment discontinuation.

“Our findings support camrelizumab plus rivoceranib with TACE as a potential new treatment option for TACE-eligible unresectable HCC,” concluded Peng and study authors.

Reference

Jia W, Qin S, Zhou J, et al. Camrelizumab (C) plus rivoceranib (R) with transarterial chemoembolization (TACE) vs. TACE alone in unresectable hepatocellular carcinoma (uHCC): a randomized, phase 3 trial. J Clin Oncol. 2026;44(suppl 16):4001. doi:10.1200/JCO.2026.44.16_suppl.4001