Status:
RECRUITING
EGCG for Hepatocellular Carcinoma Chemoprevention
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Cirrhosis, Liver
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 clinica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06015022
Start Date
September 1 2024
End Date
August 31 2028
Last Update
September 5 2025
Active Locations (1)
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1
UT Southwestern
Dallas, Texas, United States, 75390