drugset / Trial / NCT05920863

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

NCT05920863 ↗

Phase 2 Recruiting 35 enrolled Zhejiang Cancer Hospital
NaSingle-groupOpen-labelTreatment

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)

Timeline

Start
2023-07-01
Primary completion
2025-12-31
Completion
2025-12-31

Drugs

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