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Taking people in United StatesPhase 2

Tests EGCG to help prevent liver cancer in people with cirrhosis

Tests EGCG, a green tea compound, in adults with liver cirrhosis.

Key facts

Who runs it
University of Texas Southwestern Medical Center
Where
Dallas, United StatesSee the site
Trial code
Registry title
EGCG for Hepatocellular Carcinoma Chemoprevention
Status
Recruiting
Phase
Phase 2
People taking part
60 people, planned
Started
1 Sept 2024
Expected to end
31 Aug 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Epigallocatechin gallate (EGCG)
  • Placebo
Record updated
5 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with liver cirrhosis who have never had liver cancer. It tests whether EGCG can help prevent liver cancer (hepatocellular carcinoma).

Age
18 years or older
Sex
Men and women can join.
Disease stage
Cirrhosis diagnosed by a doctor and/or by tissue test, with no active hepatic decompensation. FIB-4 index above 3.25. Karnofsky performance status score of 70 or more.
Earlier treatment
No prior or ongoing use of EGCG.
Biomarker or test result
High-risk PLSec at baseline. HLA-B*35:01 must be absent.

Main reasons for not taking part

  • Past history of hepatocellular carcinoma (HCC)
  • Past bad reaction to green tea products
  • Severe obesity (BMI above 40 kg/m2)
  • Active drinking
  • Poor blood, liver or kidney function

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in United States

  • UT SouthwesternDallas, United StatesContact: Yujin HoshidaTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Epigallocatechin gallate 600 - 800mgTreatment being tested

    Epigallocatechin gallate (EGCG) 600mg will be administered daily via oral route for the initial 12 consecutive weeks on an outpatient basis. The dose of 600 mg will be continued for the second 12 weeks if an interim HCC biomarker test at the end of week 8 improves. If the interim test does not improve without dose-limiting adverse events, the dose will be increased to 800mg for the second 12 weeks, All participants will receive 24 weeks of treatment in total.

    Treatment: Epigallocatechin gallate (EGCG)

  • PlaceboPlacebo, for comparison

    Oral administration of placebo for 24 weeks

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase II Randomized Controlled Trial of Epigallocatechin Gallate for Hepatocellular Carcinoma Chemoprevention
Plain-language title
Tests EGCG to help prevent liver cancer in people with cirrhosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
5 September 2025