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NOT YET RECRUITING
NCT07518706
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Official title: A Phase II Study Comparing Neoadjuvant Tislelizumab Plus Lenvatinib Followed by Surgery Versus Surgery Alone in Patients With Stage Ia Hepatocellular Carcinoma and an Anticipated Narrow Surgical Margin

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-04-30

Completion Date

2029-04-30

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

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.