CARES-009 phase 2/3 trial

The CARES-009 phase 2/3 trial investigated the efficacy of perioperative camrelizumab plus rivoceranib in patients with hepatocellular carcinoma (HCC) at intermediate or high risk of relapse. The trial aimed to determine whether combining immunotherapy and targeted therapy before and after surgery could improve outcomes compared to surgery alone. In the study, 294 patients were randomly assigned to two groups: one receiving perioperative therapy (neoadjuvant and adjuvant camrelizumab plus rivoceranib) and the other undergoing surgery alone.

Results showed that patients in the perioperative therapy group had significantly improved event-free survival (EFS) with a median of 42.1 months compared to 19.4 months in the surgery-alone group (HR 0.59, p=0.0040). However, adverse events of grade 3 or higher occurred in 38% of patients receiving perioperative therapy, including two treatment-related deaths during neoadjuvant therapy. This trial highlights the potential benefits of perioperative immunotherapy but underscores the importance of managing associated risks.