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EGCG for Liver Cancer Prevention in Cirrhosis

This study is testing if epigallocatechin gallate (EGCG), a substance found in green tea, can help prevent liver cancer (hepatocellular carcinoma or HCC) in people with cirrhosis. You might be able to join if you are an adult with cirrhosis, have good overall health, and no history of liver cancer. The study will look at whether EGCG can improve a specific marker in your blood called PLSec, which is linked to liver cancer risk. Sixty participants will receive either EGCG or a placebo (an inactive substance) for 24 weeks. The main goal is to see how EGCG affects your PLSec score compared to the placebo.

Study design
This is an interventional study with 60 participants. You will be randomly assigned to receive either EGCG or a placebo.
What's involved
You will take capsules of EGCG or placebo for 24 weeks. Your dose might change after 12 weeks based on an interim analysis.
Compensation
Not stated in the trial record.
Follow-up
Your PLSec test will be measured at baseline and again at week 24, after the treatment period ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06015022

EGCG for Hepatocellular Carcinoma Chemoprevention

Recruiting
PHASE2Ages 18+InterventionalPrevention
University of Texas Southwestern Medical Center
~60 participants
Updated 2025-09-05 on ClinicalTrials.gov
What's tested:Epigallocatechin gallate (EGCG)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Prognostic Liver Secretome signature (PLSec) score
Measured over Baseline to week 24

Conditions

Cirrhosis, Liver

Explore related trials

CirrhosisPLEC Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Yujin Hoshida, MD, PhD · PRINCIPAL_INVESTIGATOR · UT Southwestern

Who to contact

Yujin Hoshida, MD, PhD
[email protected]
214-648-3111
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults (≥ 18 years-old)
Clinically and/or histologically diagnosed cirrhosis
No active hepatic decompensation
No prior history of HCC
Adequate hematologic, hepatic, and renal function
Karnofsky performance status score ≥70
Both sexes and all racial/ethnic groups will be considered
FIB-4 index \> 3.25
High-risk PLSec at baseline
Absence of HLA-B\*35:01

Exclusion

Prior or ongoing use of EGCG
History of adverse reaction to green tea products
Severe obesity (BMI \> 40 kg/m2)
Active drinking
EGCG treatment \<4 weeks or \<80% of planned regimen at the end of week 4
HCC development during the study

What this trial measures

  • Change in Prognostic Liver Secretome signature (PLSec) scoreBaseline to week 24

    HCC risk level at baseline and post-treatment will be determined as Prognostic Liver Secretome signature (PLSec) score, ranging from 0 (lowest risk) to 8 (highest risk). Change in the biomarker-based HCC risk level will be calculated as delta-PLSec by subtracting the post-treatment PLSec score from the baseline pre-treatment PLSec score. delta-PLSec values will be compared between the EGCG and placebo arms using two-sample t-test.