Phase II Randomized Controlled Trial of Epigallocatechin Gallate for Hepatocellular Carcinoma Chemoprevention
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Texas
UT Southwestern
RECRUITING
Dallas
Contact Information
Primary
Yujin Hoshida, MD, PhD
yujin.hoshida@utsouthwestern.edu
214-648-3111
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 60
Treatments
Experimental: Epigallocatechin gallate 600 - 800mg
Epigallocatechin gallate (EGCG) 600mg will be administered daily via oral route for the initial 12 consecutive weeks on an outpatient basis. The dose of 600 mg will be continued for the second 12 weeks if an interim HCC biomarker test at the end of week 8 improves. If the interim test does not improve without dose-limiting adverse events, the dose will be increased to 800mg for the second 12 weeks, All participants will receive 24 weeks of treatment in total.
Placebo_comparator: Placebo
Oral administration of placebo for 24 weeks
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center