Unresectable hepatocellular carcinoma.
Conditions
Interventions
Lenvatinib + Pembrolizumab + Branched-Chain Amino Acids (BCAA) group:Lenvatinib + Pembrolizumab + Branched-Chain Amino Acids (BCAA)
Lenvatinib + Pembrolizumab group:Lenvatinib + Pembrolizumab
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years and = 1.5×10^9/L, hemoglobin >= 9.0 g/dL, platelets >= 100×10^9/L; 8. Liver and kidney function: Total bilirubin <= 1.5 times the upper limit of normal; AST and ALT <= 5 times the upper limit of normal; creatinine <= 1.5 times the upper limit of normal; 9. Coagulation function: International Normalized Ratio (INR) and activated partial thromboplastin time <= 1.5 times the upper limit of normal; 10. Patients of childbearing potential must be willing to use highly effective contraception during the study and for at least 120 days after the last dose; female patients must have a negative urine or serum pregnancy test within 3 days before the first dose of the study drug; 11. Understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breastfeeding women; 2.Prior treatment with targeted therapies such as sorafenib or lenvatinib, or any immune checkpoint inhibitors including anti–PD-1, anti–PD-L1, anti–CTLA-4 agents, or any form of cellular immunotherapy; 3.Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment; 4.Active, uncontrolled infection, including but not limited to uncontrolled acute exacerbation of HBV/HCV, active tuberculosis, HIV infection with significantly reduced CD4 count, or severe bacterial, fungal, or viral infection requiring intravenous antibiotics; 5.History of other malignancies within 3 years prior to enrollment, except for adequately treated localized tumors (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, etc.); 6.Severe psychiatric or mental disorders; 7. Significant cardiovascular disease or heart dysfunction, including but not limited to: (1) NYHA class III–IV heart failure; (2) Myocardial infarction, severe angina, coronary stent placement, or coronary artery bypass surgery within the past 6 months; (3) Clinically significant ventricular arrhythmias or persistent atrial fibrillation; (4) Uncontrolled hypertension (blood pressure still =150/90 mmHg despite adequate medication). 8. Severe lung disease: (1) Severe COPD or interstitial lung disease requiring long-term oxygen therapy; (2) Active severe lung infection. 9. Significant kidney impairment: acute or chronic renal failure (eGFR 2.0, unless for maintenance anticoagulation). 11.Concurrent participation in another clinical trial, unless it is an observational, non-interventional study or the follow-up phase of an interventional study; 12.History of hepatic encephalopathy, refractory ascites, or hepatic/portal vein thrombosis leading to severe portal hypertension syndrome, deemed unsuitable for study treatment by the investigator; 13.Known history of severe hypersensitivity to lenvatinib, pembrolizumab, branched-chain amino acid preparations, or any of their excipients; 14.Estimated life expectancy of less than 3 months; 15.Participation in another interventional clinical trial (during the treatment phase) within 4 weeks prior to enrollment, or currently receiving treatment in another interventional study. Participants who are in the follow-up phase of another clinical trial and whose participation does not interfere with this study evaluation may be enrolled; 16.Any other condition that, in the investigator’s judgment, may compromise patient safety or interfere with the evaluation of study efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Incidence of adverse events;Overall survival; | — |
Countries
China
Contacts
Public ContactJinhong Chen
Huashan Hospital, Fudan University
Outcome results
None listed