EGCG for Hepatocellular Carcinoma Chemoprevention

NCT ID: NCT06015022

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2028-08-31

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.

Detailed Description

This study will evaluate whether EGCG favorably modulate an HCC risk biomarker (PLSec) with acceptable safety profile in patients with compensated cirrhosis and elevated HCC risk determined by clinical variable-based score (FIB-4 index) and PLSec. Sixty participants will be randomized (1:1) to either the study drub or placebo arm and receive the treatment for 24 weeks. The participants will orally take EGCG 600 mg capsules or placebo for the first 12 weeks. If an interim PLSec analysis at the end of week 8 is not improved without any dose-limiting adverse events, the dose will be increased to 800 mg for the second 12 weeks. If the interim PLSec is improved, 600 mg will be continued. After completing the 24-week treatment, change in the PLSec test with the treatment is calculated by comparing pre- and post-treatment serum samples in each patient, and the changes will be compared between the treatment arms (primary endpoint). Complete adverse event profiles will be recorded, and change in quality of life will be compared between the treatment arms (secondary endpoints). If optional paired liver biopsy tissues are obtained, changes in tissue-based HCC risk biomarker (PLS) and immunohistochemical markers of cell proliferation, neoplasm, senescence, and fibrogenesis will be determined, changes in the FIB-4 index and liver stiffness measurement will be determined, and association with incident HCC during the study period will be evaluated (exploratory endpoints).

Conditions

Cirrhosis, Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Epigallocatechin gallate (EGCG)

Intervention Type: DRUG

EGCG is a green tea-derived catechin

Placebo

Oral administration of placebo for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Epigallocatechin gallate (EGCG)

EGCG is a green tea-derived catechin

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Teavigo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yujin Hoshida, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yujin Hoshida, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

UT Southwestern

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yujin Hoshida, MD, PhD

Role: CONTACT

yujin.hoshida@utsouthwestern.edu

214-648-3111

Facility Contacts

Yujin Hoshida

Role: primary

yujin.hoshida@utsouthwestern.edu

214-648-3111

Other Identifiers

STU-2023-0233

Identifier Type: -

Identifier Source: org_study_id