RecruitingPhase 2NCT07099274

Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma

A Single-Arm, Single-Center Clinical Study Evaluating the Efficacy and Safety of Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib as Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

29 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Major objectives To evaluate the efficacy of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two checkpoint immunotherapy drugs (lparomlimab and tuvonralimab) together with a procedure called TACE (which delivers chemotherapy directly into liver tumors via a blood vessel) and a targeted drug (lenvatinib) for people with advanced liver cancer (hepatocellular carcinoma) whose disease got worse after prior immunotherapy plus bevacizumab. **You may be eligible if...** - You are 18 or older - You have confirmed liver cancer (hepatocellular carcinoma) - Your cancer progressed or you could not tolerate prior treatment with a PD-1 blocker plus bevacizumab - You have at least one measurable tumor - Your liver is functioning reasonably well (Child-Pugh A or B, score ≤7) - Your life expectancy is at least 3 months - Active hepatitis B or C is being treated with antiviral medication **You may NOT be eligible if...** - You have had a liver transplant or are on a transplant list - You have cancer that has spread to the brain - You have severe portal vein tumor blockage (Vp4) - You have serious uncontrolled high blood pressure, heart disease, or heart failure - You have bleeding tendencies or had a stroke in the past 12 months - You are pregnant or breastfeeding 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

DRUGlparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib

lparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg/kg, q3w; Lenvatinib: 8 mg once daily for patients weighing \<60 kg, or 12 mg once daily for those weighing ≥60 kg, administered orally, continuous daily dosing; TACE: Administered 4-6 times, using a combination of anthracyclines, lipiodol, and microspheres. The procedure should be performed within one week before or after QL1706 administration.


Locations(1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

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NCT07099274


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