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RECRUITING
NCT05920863
PHASE2

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

Sponsor: Zhejiang Cancer Hospital

View on ClinicalTrials.gov

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)

Official title: 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: Study Protocol of a Monocenter, Single-arm, Open Label Clincal Trail

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2023-07-01

Completion Date

2025-12-31

Last Updated

2025-02-11

Healthy Volunteers

No

Interventions

PROCEDURE

TACE

TACE: pharmorubicin 30mg, oxaliplatin 50mg, cycle 4-5 week.

DRUG

Tislelizumab, Lenvatinib

Tislelizumab: 200mg, cycle 3 week. Lenvatinib: weight \<60kg, 8mg/day; weight ≥60kg, 12mg/day.

Locations (1)

1# Banshan East Rd. Zhejiang cancer hospital

Hangzhou, Zhejiang, China