Lenvatinib and Pembrolizumab With or Without BCAA in Unresectable HCC
ConditionHCC - Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
The goal of this clinical trial is to learn whether adding branched-chain amino acids (BCAAs) to lenvatinib and pembrolizumab improves treatment outcomes in adults with unresectable hepatocellular carcinoma (HCC). The study will also evaluate the safety of this combination treatment.
The main questions this study aims to answer are:
Does the addition of BCAAs improve the time patients live without their cancer getting worse? Does the combination treatment improve tumor response compared with standard treatment alone? What medical problems or side effects do participants experience during treatment? Researchers will compare lenvatinib plus pembrolizumab with BCAAs to lenvatinib plus pembrolizumab alone to see whether adding BCAAs provides additional benefit for patients with unresectable HCC.
Participants will:
Be randomly assigned to receive lenvatinib and pembrolizumab with or without oral BCAAs Take lenvatinib by mouth every day and receive pembrolizumab by intravenous infusion every 3 weeks Continue treatment until disease progression, unacceptable side effects, or withdrawal from the study Visit the clinic regularly for physical examinations, imaging tests, blood tests, and safety assessments
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥18 years and <75 years at the time of enrollment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically or cytologically confirmed hepatocellular carcinoma (HCC), excluding fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular-cholangiocarcinoma; or clinically diagnosed HCC according to the American Association for the Study of Liver Diseases (AASLD) criteria.
Unresectable Barcelona Clinic Liver Cancer (BCLC) stage B or C disease, as assessed by the investigator.
Disqualifiers
Pregnant or breastfeeding women.
Prior treatment with systemic targeted therapies (including sorafenib or lenvatinib), immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), or any form of cellular immunotherapy.
Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapies (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatment.
Active or uncontrolled infection, including but not limited to uncontrolled acute exacerbation of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active tuberculosis, human immunodeficiency virus (HIV) infection with significantly reduced CD4 counts, or severe bacterial, fungal, or viral infections requiring intravenous antimicrobial therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Lenvatinib
DrugLenvatinib is administered orally once daily at a dose of 12 mg for participants with body weight ≥60 kg or 8 mg for participants with body weight \<60 kg. Treatment is continued in 21-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Pembrolizumab
DrugPembrolizumab is administered as an intravenous infusion at a fixed dose of 200 mg on Day 1 of each 21-day treatment cycle. Treatment is continued for up to 2 years or until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Branched-Chain Amino Acids
DrugBranched-chain amino acids (BCAA) are administered orally at a dose of 6 g twice daily (po bid). BCAA supplementation is continued throughout the treatment period unless discontinued due to intolerance, withdrawal of consent, or investigator decision.
Treatment groups
234 Participants
are divided into 2 treatment groupsGroup A: Lenvatinib + Pembrolizumab + BCAAExperimental treatment 3 interventions
Group B: Lenvatinib + PembrolizumabActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
Progression-free survival (PFS), defined as the time from randomization to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Time frame
From randomization until disease progression or death, assessed up to approximately 24 monthsSecondary outcomes
1
Overall Survival (OS)
Overall survival (OS), defined as the time from randomization to death from any cause.
Time frame
From randomization until death from any cause, assessed up to approximately 36 months.2
Objective Response Rate (ORR)
Objective response rate (ORR), defined as the proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST version 1.1.
Time frame
Assessed from baseline until disease progression, assessed up to approximately 24 months.3
Disease Control Rate (DCR)
Disease control rate (DCR), defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1.
Time frame
Assessed from baseline until disease progression, assessed up to approximately 24 months.4
Incidence and Severity of Adverse Events
Incidence and Severity of Adverse Events
Time frame
From first dose of study treatment until 30 days after the last dose.Other outcomes
1
Exploratory Biomarker Analyses
Exploratory analyses to evaluate the associations between gene expression profiles and immune cell distributions in tumor tissue and peripheral blood, and clinical efficacy and prognosis in study participants.
Time frame
From baseline through disease progression or end of study follow-up, assessed up to approximately 36 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: