Phase 3 Study of Neoadjuvant Tislelizumab Plus Lenvatinib Before Surgery in Adults With Resectable Liver Cancer at High Risk of Recurrence

What this Trial Is About

This research aims to evaluate the effectiveness and safety of neoadjuvant tislelizumab combined with lenvatinib in patients who have resectable hepatocellular carcinoma HCC and are at high risk of cancer recurrence after surgery. Hepatectomy is the main curative treatment for HCC, but a high rate of postoperative recurrence limits long-term survival. Previous studies suggest that combining immune checkpoint inhibitors with antiangiogenic agents may provide benefits in the perioperative setting for HCC. Participants are randomly assigned to one of two groups. One group undergoes surgery alone after enrollment, while the other group receives two cycles of neoadjuvant tislelizumab 200 mg intravenously every 3 weeks plus lenvatinib 8 mg or 12 mg orally daily based on body weight before surgery. Each treatment cycle lasts three weeks, and the neoadjuvant treatment group completes two cycles prior to surgery. This is a phase 3, multicenter, randomized controlled trial. During the study, participants are monitored for outcomes such as the 1-year event-free survival rate, objective response rate, disease control rate, major pathologic response, recurrence-free survival up to 36 months, overall survival up to 48 months, and safety events related to treatment and surgery delays. Researchers collect data through scheduled assessments over the course of the study, which may last several years. Participants must comply with follow-up visits and evaluations as part of the trial.

A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence