Single-center phase 2 trial of perioperative tislelizumab plus lenvatinib for resectable hepatocellular carcinoma at high risk of recurrence

Postoperative recurrence significantly impacts long-term survival in patients with resectable hepatocellular carcinoma (HCC). A phase 2 trial at Tianjin Medical University (China) evaluated the perioperative combination of tislelizumab (anti-PD-1) and lenvatinib (multikinase inhibitor) for 27 patients with HCC at high risk of recurrence. Co-primary endpoints were safety and feasibility. The regimen was feasible and generally well tolerated: grade 3 treatment-related adverse events occurred in 7.4% of patients and no unexpected safety signals were observed. The objective response rate was 55.6%. Among 20 patients undergoing surgery, 20% achieved pathologic complete response, and the median disease-free survival was 18.8 months, with 1- and 2- year DFS of 74.0% and 49.8%. The authors conclude that tislelizumab-lenvatinib is a potential perioperative regimen for resectable HCC at high risk of recurrence.