Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * Comprehension and voluntary signing of the study's informed consent form; * Age ≥18 years, any gender; * Histologically or clinically confirmed hepatocellular carcinoma; * Documented failure or intolerance to first-line therapy with PD-1/PD-L1 inhibitor plus bevacizumab; * ECOG performance status 0-2; * Child-Pugh class A or class B (score ≤7) without hepatic encephalopathy history; * Life expectancy ≥3 months; * At least one measurable target lesion confirmed by screening imaging per RECIST v1.1; * Adequate organ and bone marrow function within 7 days prior to initial study treatment; * Active HBV/HCV infection requires ongoing antiviral therapy; k.Fertile patients must use highly effective contraception with partners during treatment and ≥180 days post-last dose. 2.Exclusion Criteria: * Inability to comply with the study protocol or procedures; * Histologically/cytologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or mixed hepatocellula