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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

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

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I am able to care for myself but may not be able to do active work.

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I am 18 years old or older.

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My liver is functioning properly.

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I have never had liver cancer.

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I do not have the HLA-B*35:01 gene.

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I have been diagnosed with cirrhosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used or am using EGCG.

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My condition developed liver cancer during the study.

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My BMI is over 40.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ average time frame of 1 year

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

Headaches

Migraine after vaccine

Diarrhea

100%

80%

60%

40%

20%

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

0 / 9Eligibility criteria met