EGCG for Hepatocellular Carcinoma Chemoprevention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epigallocatechin gallate (EGCG), Placebo.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Liver. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Randomized Controlled Trial of Epigallocatechin Gallate for Hepatocellular Carcinoma Chemoprevention
Overview
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).
Interventions
- Drug Epigallocatechin gallate (EGCG)
EGCG is a green tea-derived catechin - Other Placebo
Placebo in the same capsule with the experimental agent (EGCG).
Primary outcome measures
- Change in Prognostic Liver Secretome signature (PLSec) score [Time frame: Baseline to week 24]
Secondary outcome measures (2)
- Complete adverse event profile [Time frame: Baseline to week 24]
- Change in quality of life measured by the chronic liver disease questionnaire [Time frame: Baseline to week 24]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UT Southwestern — Dallas
Identifiers
NCT: NCT06015022 · STU-2023-0233