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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2025-02-11
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)
Conditions
- Hepatocellular Carcinoma
- Lenvatinib
- Tislelizumab
- TACE
- Pharmorubicin
- Oxaliplatin
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.
Sponsors & Collaborators
-
Zhejiang Cancer Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-01
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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