In a Chinese phase II trial (CHANCE2005/CARES-005) reported in the Journal of Clinical Oncology, Zhu et al found that the addition of camrelizumab and rivoceranib to transarterial chemoembolization (TACE) improved progression-free survival in patients with unresectable hepatocellular carcinoma.
Study Details
In the multicenter open-label trial, 200 patients were randomly assigned between December 2020 and October 2023 to receive TACE with (n = 100) or without (n = 100) camrelizumab at 200 mg every 3 weeks and rivoceranib at 250 mg once daily (TACE-C-R). The primary endpoint was progression-free survival using 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.
Key Findings
Median follow-up was 14.3 months (interquartile range = 8.3–20.9 months). Median progression-free survival on composite criteria was 10.8 months (95% confidence interval [CI] = 8.8–13.7 months) in the TACE-C-R group vs 3.2 months (95% CI = 2.4–4.2 months) in the TACE group (hazard ratio [HR] = 0.34, 95% CI = 0.24–0.50, P < .001).
Median progression-free survival on modified RECIST criteria alone was 8.8 months (95% CI = 6.2–10.8 months) in the TACE-C-R group vs 3.1 months (95% CI = 2.3–4.2 months) in the TACE group (HR = 0.43, 95% CI = 0.30–0.62, nominal P < .001).
Grade ≥ 3 treatment-related adverse events occurred in 74.5% of the TACE-C-R group vs 22.3% of the TACE group. The most common were increased aspartate aminotransferase (AST; 31%), increased alanine aminotransferase (ALT; 24%), hypertension (14%), and decreased platelet count (12%) in the TACE-C-R group and increased ALT (14%) and increased AST (13%) in the TACE group. Death considered at least possibly related to treatment occurred in three patients in the TACE-C-R group (due to sepsis, cerebral hemorrhage, and gastrointestinal hemorrhage) and in one patient in the TACE group (due to hepatic failure).
The investigators concluded: “The addition of camrelizumab and rivoceranib to TACE showed statistically significant improvement in [progression-free survival] for patients with unresectable [hepatocellular carcinoma], with a manageable safety profile. Follow-up for further overall survival analysis is ongoing.”
Gao-Jun Teng, MD, PhD, of the Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing, China, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by Jiangsu Hengrui Pharmaceuticals, Noncommunicable Chronic Diseases–National Science and Technology Major Project, National Natural Science Foundation of China, and others. For full disclosures of the study authors, visit ascopubs.org.
