RecruitingPhase 2NCT07317414

β-alanine in the Treatment of Advanced Hepatocellular Carcinoma

A Randomized Clinical Trial Exploring β-alanine as an Adjunct to First-line Immunotherapy in Advanced Hepatocellular Carcinoma


Sponsor

Peking Union Medical College Hospital

Enrollment

158 participants

Start Date

Dec 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a supplement called beta-alanine — a naturally occurring amino acid — can help treat advanced liver cancer (hepatocellular carcinoma) that cannot be surgically removed. **You may be eligible if...** - You are 18 or older - You have confirmed advanced or unresectable liver cancer (hepatocellular carcinoma), either BCLC stage C or certain BCLC stage B cases - Your cancer has measurable tumors on imaging - At least 4 weeks have passed since your last local liver treatment (such as embolization, ablation, or radiation) - You are using effective contraception if you are of childbearing age **You may NOT be eligible if...** - You have not yet tried any local treatments and are still eligible for surgery - Your cancer has spread significantly to lymph nodes or distant organs in ways that fall outside study criteria - Your organ function (liver, kidneys, blood) is too compromised - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab combined with bevacizumab combined with β- alanine

Atezolizumab (Tecentriq®) + Bevacizumab (Avastin®)+β- alanine

DRUGAtezolizumab combined with bevacizumab

Atezolizumab (Tecentriq®) + Bevacizumab (Avastin®)


Locations(3)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

View Full Details on ClinicalTrials.gov

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NCT07317414


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