EGCG for Hepatocellular Carcinoma Chemoprevention
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.
| Condition(s) | Cirrhosis, Liver |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Texas Southwestern Medical Center |
| Locations | Dallas, Texas, United States |
| Start date | 2024-09-01 |
| NCT ID | NCT06015022 |
| Official listing | https://clinicaltrials.gov/study/NCT06015022 |