Perioperative Camrelizumab and Apatinib for High‐Risk Resectable Hepatocellular Carcinoma: A Phase II Study

Abstract

The optimal perioperative regimen for resectable hepatocellular carcinoma (HCC) remains undefined. This study evaluated the efficacy and safety of perioperative camrelizumab combined with apatinib in patients with resectable high‐risk HCC. In this single‐arm, phase II study, 31 patients with resectable HCC and high recurrence risk factors (e.g., large tumor size, multinodularity, and vascular invasion) received neoadjuvant camrelizumab (200 mg every 2 weeks) and apatinib (250 mg daily) for four cycles, followed by surgical resection and adjuvant therapy with the same regimen for up to 1 year. The primary endpoint was major pathological response (MPR), defined as ≤ 50% viable tumor cells in resected specimens. A total of 31 patients were enrolled in the study. Among 26 patients who underwent surgery, the MPR rate was 46.2%. The median disease‐free survival (DFS) in patients who underwent surgery was 24.1 months (95% confidence interval [CI]: 14.4–not estimable [NE]). The median progression‐free survival (PFS) in all patients was 18.3 months (95% CI: 11.6–NE). In the neoadjuvant setting, Grade 3 or higher adverse events were observed in 12.9% of patients. Perioperative camrelizumab combined with apatinib demonstrated promising efficacy and manageable safety in high‐risk resectable HCC.