EGCG for Hepatocellular Carcinoma Chemoprevention

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

EGCG for Hepatocellular Carcinoma Chemoprevention

Condition
Cirrhosis, Liver
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Yujin Hoshida, MD, PhD, PRINCIPAL_INVESTIGATOR, UT Southwestern

Study Record Dates

2028-08-31