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Trial Title:
EGCG for Hepatocellular Carcinoma Chemoprevention
NCT ID:
NCT06015022
Condition:
Cirrhosis, Liver
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Cirrhosis
Epigallocatechin gallate
Conditions: Keywords:
hepatocellular carcinoma
chemoprevention
liver cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized placebo-controlled trial
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Double-blinded
Intervention:
Intervention type:
Drug
Intervention name:
Epigallocatechin gallate (EGCG)
Description:
EGCG is a green tea-derived catechin
Arm group label:
Epigallocatechin gallate 600 - 800mg
Other name:
Teavigo
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo in the same capsule with the experimental agent (EGCG).
Arm group label:
Placebo
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 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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UT Southwestern
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yujin Hoshida
Phone:
214-648-3111
Email:
yujin.hoshida@utsouthwestern.edu
Start date:
September 1, 2024
Completion date:
August 31, 2028
Lead sponsor:
Agency:
University of Texas Southwestern Medical Center
Agency class:
Other
Source:
University of Texas Southwestern Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06015022
