Camrelizumab combined with rivoceranib and TACE in the perioperative treatment of hepatocellular carcinoma: A randomized, open-label multicenter trial.

Abstract

e16279 Background: The high recurrence rate following resection presents a significant challenge to the survival of patients with resectable hepatocellular carcinoma (HCC). Therefore, it is imperative to develop novel and effective therapeutic interventions to reduce recurrence and improve the prognosis of patients with resectable HCC. This study aims to evaluate the efficacy and safety of camrelizumab combined with rivoceranib and TACE as a perioperative treatment regimen in patients with HCC. Methods: In this multicenter, randomized clinical trial, eligible HCC patients (CNLC stages Ib-IIIa) were randomly assigned in a 1:1 ratio to either the treatment or control group. Patients in the treatment group received one cycle of TACE, followed by 2 cycles of camrelizumab (200 mg Q2W) combined with rivoceranib (250 mg QD), and subsequently proceeded to surgery. At least six cycles of sequential therapy of camrelizumab (200 mg Q3W) plus rivoceranib (250 mg QD) was performed postoperatively.Patients in the control group received surgical resection followed by at least six cycles of treatment with camrelizumab (200 mg Q3W) plus rivoceranib (250 mg QD). The primary endpoint was 2-year event-free survival rate. Secondary endpoints were major pathological response (MPR) (defined as ≤10% viable tumor cells in the tumor bed), pathologic complete response rate (pCR), disease-free survival (DFS), overall survival (OS), and safety. Results: From March 2023 to November 2024, 60 patients with HCC were enrolled and randomly assigned to the treatment (31 patients) or control (29 patients) group. The median age of the enrolled subjects was 60 years (range: 31-76). Among them, 43 (71.7%) had hepatitis B virus (HBV) infection. In the treatment group, 28 patients received neoadjuvant therapy. Of these, 24 completed two cycles of preoperative therapy and underwent with the planned surgical resection. Surgery was canceled in 4 patients: 2 refused the procedure, and 2 had disease progression. The MPR rates in the ITT population were 22.6% (7/31). The MPR rate in patients who had surgical resection were 29.2% (7/24). Grade ≥3 treatment-related adverse events (TRAEs) occurred in 5.9% of the treatment group and 10.2% of the control group. The most common TRAEs occuring in treatment group included platelet count decreased (22.5%), aspartate aminotransferase increased (19.3%) , and neutrophil count decreased (14.7%). Conclusions: The combination of camrelizumab, rivoceranib, and TACE as a perioperative treatment demonstrates both efficacy and tolerability in patients with resectable HCC. Preoperative neoadjuvant therapy has demonstrated promising pathological response. However, due to the short follow-up duration, further research is required to determine whether perioperative treatment can effectively reduce recurrence rates and improve long-term survival outcomes. Clinical trial information: NCT05613478 .