Clinical Trial

Lenvatinib Combined with Tislelizumab and TACE Applied As Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma with High-risk Recurrence Factors

Recruiting Phase 2
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Record status
This record was last updated February 11, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a monocenter, single-arm, open-label study to evaluate the efficacy and safety of Lenvatinib combined with Tislelizumab and TACE applied as neoadjuvant regimen for the patients of CNLC stage IB and IIA hepatocellular carcinoma with high risk of recurrence Primary outcome: Major pathological response (MPR) Secondary outcomes: pathological complete response (pCR), R0 resection rate, objective response rate (ORR), disease control rate (DCR), treatment-related adverse events (TRAE)
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-06-17; most recent amendment 2025-02-09.
Status change: Not Yet Recruiting → Recruiting 2023-08-22
Trial Details
NCT Number NCT05920863
Lead Sponsor Zhejiang Cancer Hospital
Conditions Hepatocellular Carcinoma, Lenvatinib, Tislelizumab, TACE, Pharmorubicin, Oxaliplatin
Enrollment 35 participants
Start Date 2023-07-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-11