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Lenvatinib and Pembrolizumab With or Without BCAA in Unresectable HCC

NCT07412054 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2026-02-17

No results posted yet for this study

Summary

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

Conditions

  • HCC - Hepatocellular Carcinoma

Interventions

DRUG

Lenvatinib

Lenvatinib 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.

DRUG

Pembrolizumab

Pembrolizumab 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.

DRUG

Branched-Chain Amino Acids

Branched-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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-06-01
Completion
2028-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07412054 on ClinicalTrials.gov