RecruitingPhase 3NCT05738616

Lenvatinib Combined With TACE and Camrelizumab in Conversion Resection for Advanced Hepatocellular Carcinoma (LEN-TAC Study)

Lenvatinib Combined With Transcatheter Arterial Chemoembolization and Camrelizumab Versus Lenvatinib Combined With Transcatheter Arterial Chemoembolization in Conversion Resection for Advanced Hepatocellular Carcinoma:A Randomized, Open-label, Parallel-controlled, Phase III Study(LEN-TAC Study)


Sponsor

Wen Tianfu

Enrollment

196 participants

Start Date

May 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Compared to systemic therapy alone, conversion therapy is promising to improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). Triple therapy (lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab) may have significant efficacy in conversion therapy for patients with advanced HCC, but its safety and efficacy remain unknown. To address this, we have designed a randomized, open-label, parallel-controlled trial to evaluate the safety and efficacy of lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab versus lenvatinib combined with transcatheter arterial chemoembolization in conversion resection for advanced HCC. Totally 196 patients with BCLC C stage HCC will be rigorously screened and included, and the primary endpoints of the study are overall survival. This study aims to provide valuable insights into new treatment strategies for advanced HCC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach — lenvatinib (a targeted drug), TACE (a procedure that delivers chemotherapy directly into liver tumors via blood vessels), and camrelizumab (an immunotherapy) — to potentially shrink advanced liver cancer enough to make surgery possible. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced hepatocellular carcinoma (primary liver cancer) - You have not previously received anticancer treatment for liver cancer (or have had at most 2 TACE procedures) - Your liver function is relatively preserved (Child-Pugh class A or B) - Your cancer is in one half of the liver with involvement of the portal vein but not spreading outside the liver - Your general health status is good (ECOG score 0–1) - Your hepatitis B viral load is under control (if applicable) **You may NOT be eligible if...** - Your cancer has spread outside the liver - You have a different type of liver cancer (e.g., cholangiocarcinoma or mixed type) - You have severe liver, kidney, or blood pressure problems that are uncontrolled - You are pregnant or planning to become pregnant 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

COMBINATION_PRODUCTLenvatinib combined with TACE and Camrelizumab

Once subjects have signed the informed consent and passed screening, they will be randomized in a 1:1 ratio to either the experimental arm (lenvatinib combined with TACE and camrelizumab) or the control arm (lenvatinib combined with TACE).


Locations(1)

HuaXi hospital

Chengdu, Sichuan, China

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NCT05738616


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