← Back to Search

Cancer Vaccine

EGCG for Liver Cancer Prevention (CATCH-B Trial)

Phase 2
Recruiting
Led By Yujin Hoshida, MD, PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance status score ≥70
Adults (≥ 18 years-old)
Must not have
Prior or ongoing use of EGCG
HCC development during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average time frame of 1 year
Awards & highlights

Summary

"This trial is testing a substance called epigallocatechin gallate (EGCG) to see if it can prevent liver cancer in patients with liver cirrhosis."

Who is the study for?
This trial is for adults over 18 with liver cirrhosis, a FIB-4 index above 3.25, and no history of liver cancer. They must have good blood, liver, and kidney function and be able to perform daily activities well. All genders and ethnicities are welcome if they don't have the HLA-B*35:01 gene or active worsening of their liver condition.
What is being tested?
The study is testing EGCG's ability to prevent liver cancer in patients with cirrhosis. Participants will either receive EGCG or a placebo (a substance with no therapeutic effect) to compare outcomes between the two groups.
What are the potential side effects?
Potential side effects of EGCG may include stomach upset, constipation, nausea, dizziness, muscle pain or headache; however specific side effects related to this trial are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am able to care for myself but may not be able to do active work.
Select...
I am 18 years old or older.
Select...
My liver is functioning properly.
Select...
I have never had liver cancer.
Select...
I do not have the HLA-B*35:01 gene.
Select...
I have been diagnosed with cirrhosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have used or am using EGCG.
Select...
My condition developed liver cancer during the study.
Select...
My BMI is over 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average time frame of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and average time frame of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Prognostic Liver Secretome signature (PLSec) score
Secondary study objectives
Change in quality of life measured by the chronic liver disease questionnaire
Complete adverse event profile
Other study objectives
Change in hepatic gene expression-based HCC risk biomarker, Prognostic Liver Signature (PLS) (optional)
Change in positive signal intensities of immunohistochemistry markers (optional)
HCC incidence

Side effects data

From 2022 Phase 1 trial • 39 Patients • NCT04177693
6%
Headaches
6%
Migraine after vaccine
6%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
EGCG Daily Alone.
EGCG With Clomiphene Citrate
EGCG With Letrozole

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Epigallocatechin gallate 600 - 800mgExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Oral administration of placebo for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epigallocatechin gallate (EGCG)
2020
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,072 Previous Clinical Trials
1,056,202 Total Patients Enrolled
7 Trials studying Liver Cirrhosis
7,082 Patients Enrolled for Liver Cirrhosis
Yujin Hoshida, MD, PhDPrincipal InvestigatorUT Southwestern
~40 spots leftby Aug 2028
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