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NCT06015022RecruitingPhase 2

EGCG for Hepatocellular Carcinoma Chemoprevention

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

Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
9 Aug 2023
Start date
1 Sept 2024
Primary completion date
31 Aug 2028
Lead sponsor
University of Texas Southwestern Medical Center
NCT number
NCT06015022

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 1 Sept 2024 to the primary completion date, 31 Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior or ongoing use of EGCG

Other illness

  • History of adverse reaction to green tea products

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UT Southwestern
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.