EGCG for Hepatocellular Carcinoma Chemoprevention

• Status: Not yet recruiting
• Trial end date: 2028-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Epigallocatechin gallate

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