Phase II Randomized Controlled Trial of Epigallocatechin Gallate for Hepatocellular Carcinoma Chemoprevention
University of Texas Southwestern Medical Center
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugEpigallocatechin gallate (EGCG)
EGCG is a green tea-derived catechin
- OtherPlacebo
Placebo in the same capsule with the experimental agent (EGCG).
Location
- UT SouthwesternDallas, Texas