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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.
Full description
This single-arm, single-center clinical study aims to evaluate the efficacy and safety 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. This study consists of three phases: screening, treatment, and follow-up. Efficacy evaluation and safety monitoring should be performed throughout the study.
Enrollment
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Inclusion and exclusion 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 hepatocellular-cholangiocarcinoma;
History of liver transplantation or planned transplantation;
Presence of central nervous system metastases and/or leptomeningeal carcinomatosis;
Baseline imaging showing Vp4 portal vein tumor thrombosis;
Hypersensitivity to any study drug components or history of severe allergic reactions;
Concurrent HBV and HCV co-infection;
Clinically significant ascites requiring intervention during screening;
Concurrent use of other investigational drugs or participation in another clinical trial within 4 weeks prior to enrollment;
Esophageal/gastric variceal bleeding due to portal hypertension within 6 months before treatment initiation, or high-risk varices on endoscopy within 3 months;
Current interstitial lung disease (ILD), history of steroid-required ILD, or other pulmonary fibrosis/organizing pneumonia affecting immune-related pulmonary toxicity assessment;
Uncontrolled hypertension (SBP≥160 mmHg and/or DBP≥100 mmHg despite medication), coronary artery disease, arrhythmias, or heart failure (NYHA Class ≥II);
Uncontrolled clinically significant infections requiring IV antimicrobial therapy;
Proteinuria ≥2+ (≥1.0g/24h);
History of hemorrhagic tendency regardless of severity within 2 months prior to enrollment;
Arterial/venous thromboembolic events within 12 months before treatment initiation (e.g., cerebrovascular accident including TIA);
Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment;
Unhealed fractures or chronic non-healing wounds;
Coagulopathy, bleeding diathesis, or current therapeutic anticoagulation;
Other malignancies within 5 years except curatively resected basal/squamous cell skin carcinoma or cervical carcinoma in situ;
Active autoimmune disease or autoimmune disease history requiring immunosuppression within 4 weeks prior to enrollment;
Prior allogeneic bone marrow or solid organ transplantation;
Investigator assessment of ineligibility based on medical/safety reasons.
Primary purpose
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Interventional model
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29 participants in 1 patient group
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Central trial contact
Tongguo Si, Doctor
Data sourced from clinicaltrials.gov
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