RecruitingPhase 2NCT05920863

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

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


Sponsor

Zhejiang Cancer Hospital

Enrollment

35 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving liver cancer patients three treatments together — lenvatinib (a targeted drug), tislelizumab (an immunotherapy), and TACE (a procedure that delivers chemotherapy directly to the liver tumor and blocks its blood supply) — before surgery can reduce the chances of the cancer coming back after the operation. This is for patients with early to intermediate-stage liver cancer that has features suggesting a higher risk of recurrence. **You may be eligible if:** - You are 18–75 years old - You have been diagnosed with hepatocellular carcinoma (liver cancer) at CNLC stage IB or IIA - Your imaging shows narrow or no surgical margins, and your tumor marker levels (AFP + PIVKA combined) are elevated above a specific threshold - You have not received any prior chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatment for this liver cancer - Your liver function is well-preserved (Child-Pugh grade A) and you are in good general health **You may NOT be eligible if:** - You have already received systemic anti-cancer treatment for liver cancer - Your liver function is significantly impaired - Your blood counts or organ function do not meet the required levels for surgery and treatment - Your expected survival is less than 16 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETACE

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

DRUGTislelizumab, 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

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NCT05920863


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