β-alanine in the Treatment of Advanced Hepatocellular Carcinoma

Sponsor
Peking Union Medical College Hospital
Study ID
NCT07317414
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a prospective, randomized controlled study on nutritional support and metabolic regulation. It assesses the safety, compliance, and improvement of metabolic/physical-related indicators when using β-alanine within the specified dose range as dietary supplementation, in addition to the standard first-line treatment. The anti-tumor efficacy (ORR, PFS, OS) is the exploratory endpoint.

Key Dates

Start date
Dec 24, 2025
Status verified
Dec 2025
Primary completion
Dec 5, 2028
Completion
Dec 5, 2030

Study Design

Enrollment
158 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab combined with bevacizumab combined with β- alanine
    Atezolizumab combined with bevacizumab combined with β- alanine
  • Active Comparator: Atezolizumab combined with bevacizumab
    Atezolizumab combined with bevacizumab

Primary Outcome Measure

The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale [ Time Frame: Within 7 days prior to Day 1 of each treatment cycle (each cycle is 21 days). ]

Central Contacts

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