← Back to Search

Cancer Preventive Agent

Green Tea Extract for Liver Cirrhosis

Phase 1
Waitlist Available
Led By Aiwu R He
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Absence of ascites and encephalopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to and at 1.5, 3.5, and 8.5 hours after the first dose of polyphenon e on day 1
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of defined green tea catechin extract to prevent liver cancer in people with cirrhosis.

Who is the study for?
Adults diagnosed with cirrhosis who can undergo imaging tests like ultrasound, CT, or MRI. They must have a good performance status (able to carry out daily activities), adequate blood counts and liver function, no history of certain cancers within the last 3 years except some localized ones, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with bleeding risks, allergies to green tea components, recent consumption of green tea products, other active cancers requiring systemic treatment or hepatic decompensation events.Check my eligibility
What is being tested?
The trial is testing defined green tea catechin extract's ability to prevent liver cancer in cirrhotic patients by lowering gamma-OHPdG levels. Participants will receive varying doses of this extract while being monitored through imaging studies and laboratory biomarker analysis for any changes in their condition.See study design
What are the potential side effects?
While traditional green tea consumption is generally safe over thousands of years of use, high doses as used in this study may present unknown risks. Possible side effects could include gastrointestinal issues due to the nature of the compound but specific side effects related to high-dose Polyphenon E are not well-known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or can carry out light work.
Select...
I do not have fluid buildup in my abdomen or brain function issues.
Select...
My kidney function is normal.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with cirrhosis through a biopsy, imaging, or a special liver test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to and at 1.5, 3.5, and 8.5 hours after the first dose of polyphenon e on day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to and at 1.5, 3.5, and 8.5 hours after the first dose of polyphenon e on day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in gamma-hydroxy-1,N(2)-propanodeoxyguanosine (gamma-OHPdG) expression in cirrhotic liver
Maximum tolerated dose of Polyphenon E
Secondary outcome measures
Change in gamma-OHPdG
Fraction of patients with liver cirrhosis that have high levels of gamma-OHPdG
Polyphenon E pharmacokinetic data in blood and urine in patients with cirrhosis
Other outcome measures
Grade of cirrhosis
Incidence of hepatocellular carcinoma
Liquid chromatography-mass spectrometry (LC-MS) and/or enzyme-linked immunosorbent assay (ELISA)-based method for detecting gamma-OHPdG

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (defined green tea catechin extract)Experimental Treatment9 Interventions
Participants receive defined green tea catechin extract PO QD or BID for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound, CT, or MRI at screening and on study, undergo collection of blood samples on study, and may undergo biopsy at screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1730
Biopsy
2014
Completed Phase 4
~850
Defined Green Tea Catechin Extract
2008
Completed Phase 2
~40
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Ultrasound
2013
Completed Phase 1
~1950

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,653 Total Patients Enrolled
16 Trials studying Liver Cirrhosis
11,740 Patients Enrolled for Liver Cirrhosis
Aiwu R HePrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
13 Total Patients Enrolled

Media Library

Defined Green Tea Catechin Extract (Cancer Preventive Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03278925 — Phase 1
Liver Cirrhosis Research Study Groups: Prevention (defined green tea catechin extract)
Liver Cirrhosis Clinical Trial 2023: Defined Green Tea Catechin Extract Highlights & Side Effects. Trial Name: NCT03278925 — Phase 1
Defined Green Tea Catechin Extract (Cancer Preventive Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03278925 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Defined Green Tea Catechin Extract in Preventing Liver Cancer in Participants With Cirrhosis
2018. "Defined Green Tea Catechin Extract in Preventing Liver Cancer in Participants With Cirrhosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03278925.
All > Fibrosis > Cirrhosis
~2 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top