drugset / Trial / NCT07518706

Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin

NCT07518706 ↗

Phase 2 Not yet recruiting 60 enrolled Tianjin Medical University Cancer Institute and Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Postoperative recurrence remains a major limitation to long-term survival in hepatocellular carcinoma (HCC). In addition, a narrow surgical margin is widely regarded as a risk factor for recurrence. Neoadjuvant therapy may represent a strategy to reduce the risk of recurrence, thereby improving long-term outcomes. Tislelizumab plus lenvatinib has demonstrated promising efficacy with manageable safety in advanced HCC. Therefore, we will conduct a phase II study to compare neoadjuvant tislelizumab plus lenvatinib followed by surgery versus surgery alone in patients with stage IA HCC and an anticipated narrow surgical margin.

Timeline

Start
2026-04-30
Primary completion
2028-12-30
Completion
2029-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous