Using EGCG to prevent liver cancer in patients with cirrhosis
Official title: Phase II Randomized Controlled Trial of Epigallocatechin Gallate for Hepatocellular Carcinoma Chemoprevention
Run by University of Texas Southwestern Medical Center · NCT06015022 · Data updated 2026-11-12
This study is testing if a supplement called EGCG can help prevent liver cancer in people who have cirrhosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | August 31, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | September 5, 2025 |
| Trial ID | NCT06015022 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with clinically diagnosed cirrhosis, no history of liver cancer, and elevated HCC risk as indicated by specific clinical scores.
✕Probably not a fit
Patients with active liver decompensation, severe obesity, or a history of adverse reactions to green tea products may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial investigates the effectiveness and safety of epigallocatechin gallate (EGCG) in preventing hepatocellular carcinoma (HCC) in patients diagnosed with liver cirrhosis. Participants will be randomly assigned to receive either EGCG or a placebo for 24 weeks, with dosage adjustments based on interim analysis of a specific biomarker. The primary endpoint is the change in the biomarker PLSec, while secondary endpoints include adverse events and quality of life assessments. Optional liver biopsies may provide additional insights into changes in tissue-based HCC risk markers.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of developing liver cancer in patients with cirrhosis.
How similar studies have gone: While the use of EGCG in this context is novel, previous studies have suggested potential benefits of EGCG in cancer prevention, warranting further investigation.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
UT Southwestern
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Yujin Hoshida, MD, PhD — UT Southwestern
- Study coordinator: Yujin Hoshida, MD, PhD
- Email: yujin.hoshida@utsouthwestern.edu
- Phone: 214-648-3111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.