EGCG for Hepatocellular Carcinoma Chemoprevention

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06015022
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cirrhosis, Liver

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epigallocatechin gallate (EGCG) — DRUG
    EGCG is a green tea-derived catechin
  • Placebo — OTHER
    Placebo in the same capsule with the experimental agent (EGCG).

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Aug 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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

Primary Outcome Measure

Change in Prognostic Liver Secretome signature (PLSec) score [ Time Frame: Baseline to week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT SouthwesternDallasTexas75390
Yujin Hoshida
[email protected]
214-648-3111

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By research site
UT Southwestern· Dallas, TX

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