EGCG for Hepatocellular Carcinoma Chemoprevention

NCT06015022 | Recruiting Phase 2

• 1 other identifier: STU-2023-0233
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

hepatocellular carcinoma; chemoprevention; liver cancer

Outcome Measures

Primary Outcomes (1)

• Change in Prognostic Liver Secretome signature (PLSec) score

  HCC risk level at baseline and post-treatment will be determined as Prognostic Liver Secretome signature (PLSec) score, ranging from 0 (lowest risk) to 8 (highest risk). Change in the biomarker-based HCC risk level will be calculated as delta-PLSec by subtracting the post-treatment PLSec score from the baseline pre-treatment PLSec score. delta-PLSec values will be compared between the EGCG and placebo arms using two-sample t-test.

  Baseline to week 24

Secondary Outcomes (2)

• Complete adverse event profile

  Baseline to week 24

• Change in quality of life measured by the chronic liver disease questionnaire

  Baseline to week 24

Other Outcomes (3)

• Change in hepatic gene expression-based HCC risk biomarker, Prognostic Liver Signature (PLS) (optional)

  Baseline to week 24

• Change in positive signal intensities of immunohistochemistry markers (optional)

  Baseline to week 24

• HCC incidence

  Average time frame of 1 year

Study Arms (2)

Epigallocatechin gallate 600 - 800mg

EXPERIMENTAL

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.

Drug: Epigallocatechin gallate (EGCG)

Placebo

PLACEBO COMPARATOR

Oral administration of placebo for 24 weeks

Other: Placebo

Interventions

Epigallocatechin gallate (EGCG) DRUG

EGCG is a green tea-derived catechin

Also known as: Teavigo

Epigallocatechin gallate 600 - 800mg

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Yujin Hoshida, MD, PhD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujin Hoshida, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized placebo-controlled trial

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 29, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)