NCT07475026

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

Tislelizumab Plus Lenvatinib as Neoadjuvant Therapy for Patients With Resectable HCC at High Risk of Recurrence: a Prospective, Multicenter, Randomized Controlled Phase III Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized controlled, phase 3 study to explore the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence.

Detailed description

Hepatectomy remains the primary curative treatment for HCC. However, the high rate of postoperative recurrence significantly limits long-term survival. For patients with resectable HCC at high risk of recurrence, strategies to reduce postoperative recurrence and prolong overall survival are needed. Previous studies have reported that combination regimens of immune checkpoint inhibitors plus antiangiogenic agents show promising efficacy and safety in the perioperative setting for HCC. This prospective, multicenter, randomized controlled phase 3 study aims to evaluate the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence.

Conditions

• HCC - Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab, 200mg, IV, q3w. Treatment will be given in 3-week cycles for a total of 2 cycles.
DRUG	Lenvatinib	Lenvatinib, 8mg for BW\<60kg or 12mg for BW≥60kg, PO, qd. Treatment will be given in 3-week cycles for a total of 2 cycles.

Timeline

• Start date: 2026-05-30
• Primary completion: 2030-01-31
• Completion: 2030-12-31
• First posted: 2026-03-16
• Last updated: 2026-03-16