Using EGCG to prevent liver cancer in patients with cirrhosis
Phase II Randomized Controlled Trial of Epigallocatechin Gallate for Hepatocellular Carcinoma Chemoprevention
PHASE2 · University of Texas Southwestern Medical Center · NCT06015022
This study is testing if a supplement called EGCG can help prevent liver cancer in people who have cirrhosis.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06015022 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While the use of EGCG in this context is novel, previous studies have suggested potential benefits of EGCG in cancer prevention, warranting further investigation.
Eligibility criteria
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 this trial is running
Dallas, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cirrhosis, Liver, hepatocellular carcinoma, chemoprevention, liver cancer