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

NCT07475026 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

  • HCC - Hepatocellular Carcinoma

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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2030-01-31
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07475026 on ClinicalTrials.gov