RECRUITING

EGCG for Hepatocellular Carcinoma Chemoprevention

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Conditions

Cirrhosis, Liverhepatocellular carcinomachemopreventionliver cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-01
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06015022

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (≥ 18 years-old)
  2. * Clinically and/or histologically diagnosed cirrhosis
  3. * No active hepatic decompensation
  4. * No prior history of HCC
  5. * Adequate hematologic, hepatic, and renal function
  6. * Karnofsky performance status score ≥70
  7. * Both sexes and all racial/ethnic groups will be considered
  8. * FIB-4 index \> 3.25
  9. * High-risk PLSec at baseline
  10. * Absence of HLA-B\*35:01
  1. * Prior or ongoing use of EGCG
  2. * History of adverse reaction to green tea products
  3. * Severe obesity (BMI \> 40 kg/m2)
  4. * Active drinking
  5. * EGCG treatment \<4 weeks or \<80% of planned regimen at the end of week 4
  6. * HCC development during the study

Contacts and Locations

Study Contact

Yujin Hoshida, MD, PhD
CONTACT
214-648-3111
yujin.hoshida@utsouthwestern.edu

Principal Investigator

Yujin Hoshida, MD, PhD
PRINCIPAL_INVESTIGATOR
UT Southwestern

Study Locations (Sites)

UT Southwestern
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-01
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

  • hepatocellular carcinoma
  • chemoprevention
  • liver cancer

Additional Relevant MeSH Terms

  • Cirrhosis, Liver