RecruitingPhase 2NCT06015022

EGCG for Hepatocellular Carcinoma Chemoprevention

Phase II Randomized Controlled Trial of Epigallocatechin Gallate for Hepatocellular Carcinoma Chemoprevention


Sponsor

University of Texas Southwestern Medical Center

Enrollment

60 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests epigallocatechin gallate (EGCG) for its efficacy and safety in preventing development of hepatocellular carcinoma (HCC) in patients with liver cirrhosis.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether EGCG (epigallocatechin gallate, the main active compound in green tea) can prevent liver cancer (hepatocellular carcinoma) in adults with liver cirrhosis who are at high risk of developing it. Participants take EGCG supplements daily for several months. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of liver cirrhosis - Your liver is compensated (no active decompensation such as bleeding or severe fluid buildup) - You have never had liver cancer - You have a high-risk liver lesion profile (high FIB-4 score and high-risk precancerous liver score) - You are in reasonably good overall health (Karnofsky score ≥70) - You do not carry the HLA-B*35:01 genetic variant (associated with EGCG-related liver toxicity) **You may NOT be eligible if...** - You are currently using or have previously used EGCG supplements - You have had a bad reaction to green tea products - You are severely obese (BMI >40) - You are actively drinking alcohol - You developed liver cancer during the study 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

DRUGEpigallocatechin gallate (EGCG)

EGCG is a green tea-derived catechin

OTHERPlacebo

Placebo in the same capsule with the experimental agent (EGCG).


Locations(1)

UT Southwestern

Dallas, Texas, United States

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NCT06015022


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