RecruitingPhase 2NCT07047586

Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab

Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab: a Multicenter, Randomized, Phase 2 Study


Sponsor

Fudan University

Enrollment

146 participants

Start Date

Jul 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of lenvatinib plus tislelizumab versus lenvatinib alone for patients with advanced hepatocellular carcinoma (HCC) who have progressed on prior systemic treatment with Anti-PD1/PD-L1 plus bevacizumab combination.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for advanced liver cancer (hepatocellular carcinoma, or HCC) that has already progressed after a combination of anti-PD-1/PD-L1 immunotherapy and bevacizumab: lenvatinib plus tislelizumab (an additional immunotherapy added back in) versus lenvatinib alone (a targeted therapy tablet). **You may be eligible if...** - You are 18 or older with confirmed advanced liver cancer (HCC) - Your cancer progressed after treatment with anti-PD-1/PD-L1 and bevacizumab - You have measurable disease on imaging - Your liver function score (Child-Pugh) is 5–7, and your performance status (ECOG) is 2 or lower - Your blood counts, liver enzymes, and kidney function are adequate - If you have chronic hepatitis B, your viral load is controlled with antiviral therapy **You may NOT be eligible if...** - You have rare liver cancer subtypes (fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma) - You are on a liver transplant waiting list - You had a stroke, blood clot, or significant gastrointestinal bleeding recently - You are immunocompromised (e.g., HIV positive) - You have another active cancer 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

DRUGTislelizumab

Tislelizumab will be administered by IV, 200 mg on day 1 of each 21 day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

DRUGLenvatinib

Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT07047586


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