Recruiting
Phase 2

EGCG

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06015022

Conditions

Cirrhosis, Liver

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Epigallocatechin gallate (EGCG)

Placebo

Study Details

Brief 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.

Conditions

Cirrhosis, Liver

Study ID

NCT06015022

Start date

Sep 1, 2024

Status verified date

Aug, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Epigallocatechin gallate 600 - 800mg

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.

placebo comparator: Placebo

Oral administration of placebo for 24 weeks

Interventions

Epigallocatechin gallate (EGCG)

EGCG is a green tea-derived catechin

Placebo

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

Primary outcome measure

  • Change in Prognostic Liver Secretome signature (PLSec) score [ Time Frame: Baseline to week 24 ]

Central Contacts and Locations

Central contacts

Yujin Hoshida, MD, PhD

214-648-3111yujin.hoshida@utsouthwestern.edu

Locations

UT Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Yujin Hoshida

214-648-3111yujin.hoshida@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Keywords

  • hepatocellular carcinoma
  • chemoprevention
  • liver cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-09-05.