EGCG for Hepatocellular Carcinoma Chemoprevention (CATCH-B)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06015022 |
Recruitment Status :
Not yet recruiting
First Posted : August 29, 2023
Last Update Posted : April 3, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cirrhosis, Liver | Drug: Epigallocatechin gallate (EGCG) Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized placebo-controlled trial |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double-blinded |
Primary Purpose: | Prevention |
Official Title: | Phase II Randomized Controlled Trial of Epigallocatechin Gallate for Hepatocellular Carcinoma Chemoprevention |
Estimated Study Start Date : | May 1, 2024 |
Estimated Primary Completion Date : | August 31, 2028 |
Estimated Study Completion Date : | August 31, 2028 |
Arm | Intervention/treatment |
---|---|
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.
|
Drug: Epigallocatechin gallate (EGCG)
EGCG is a green tea-derived catechin
Other Name: Teavigo |
Placebo Comparator: Placebo
Oral administration of placebo for 24 weeks
|
Other: Placebo
Placebo in the same capsule with the experimental agent (EGCG). |
- Change in Prognostic Liver Secretome signature (PLSec) score [ Time Frame: Baseline to week 24 ]
HCC risk level at baseline and post-treatment will be determined as Prognostic Liver Secretome signature (PLSec) score, ranging from 0 (lowest risk) to 8 (highest risk).
Change in the biomarker-based HCC risk level will be calculated as delta-PLSec by subtracting the post-treatment PLSec score from the baseline pre-treatment PLSec score. delta-PLSec values will be compared between the EGCG and placebo arms using two-sample t-test.
- Complete adverse event profile [ Time Frame: Baseline to week 24 ]Adverse events are monitored at least monthly and graded/recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5. The number and severity of adverse events will be tabulated and summarized across all grades. Grade 3+ adverse events will be similarly described and summarized separately.
- Change in quality of life measured by the chronic liver disease questionnaire [ Time Frame: Baseline to week 24 ]Quality of life (QOL) will be measured by using the chronic liver disease questionnaire (CLDQ), which consists of 29 questions. Participants can select one answer from seven choices of descriptive answers for each question. Frequency distributions, graphical techniques and other descriptive measures will be used to summarize the results. When frequencies are compared, Fisher's exact test will be used.
- Change in hepatic gene expression-based HCC risk biomarker, Prognostic Liver Signature (PLS) (optional) [ Time Frame: Baseline to week 24 ]When optional liver biopsy tissue is obtained, modulation of hepatic gene expression-based signature associated with HCC risk, Prognostic Liver Signature (PLS) is measured by comparing pre- and post-treatment liver biopsy samples. Change in HCC risk level will be quantified as combined enrichment score (CES) by comparing between the 2 time points. A positive and negative CES values indicate worsening and improvement of the PLS, respectively. Absolute value of the CES indicate magnitude of reduction (i.e., negative value) or increase (i.e., positive value) of HCC risk level. There is no defined range of CES. CES values are compared between the EGCG and placebo arms using two-sample t-test.
- Change in positive signal intensities of immunohistochemistry markers (optional) [ Time Frame: Baseline to week 24 ]When optional liver biopsy tissue is obtained, change of immunohistochemical markers of cellular proliferation (Ki67), hepatic neoplasia (GST-p), cellular senescence (beta-gal), fibrogenesis (alpha-SMA) will be assessed using formalin-fixed pre-treatment paraffin-embedded (FFPE) tissues. Positivity for all of the markers will be quantified by higher intensity at pixel levels in captured images using the ImageJ software. The measurements are compared between the EGCG and placebo arms using one-sample t-test.
- HCC incidence [ Time Frame: Average time frame of 1 year ]The participants will be regularly followed every 6 months for HCC development for their life time. HCC diagnosis is based on the American Association for Study of Liver Disease (AASLD) clinical practice guidelines. Time to HCC development will be calculated as days between the treatment initiation data and date of HCC diagnosis. Cumulative HCC incidence will be compared between the treatment arms using log-rank test and Cox regression within and beyond the study period. This exploratory analysis will be performed through study completion with an anticipated average time frame of 1 year.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prior or ongoing use of EGCG
- History of adverse reaction to green tea products
- Severe obesity (BMI > 40 kg/m2)
- Active drinking
- EGCG treatment <4 weeks or <80% of planned regimen at the end of week 4
- HCC development during the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06015022
Contact: Yujin Hoshida, MD, PhD | 214-648-6137 | yujin.hoshida@utsouthwestern.edu |
Principal Investigator: | Yujin Hoshida, MD, PhD | UT Southwestern |
Responsible Party: | Yujin Hoshida, MD, PhD, Professor, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT06015022 |
Other Study ID Numbers: |
STU-2023-0233 |
First Posted: | August 29, 2023 Key Record Dates |
Last Update Posted: | April 3, 2024 |
Last Verified: | April 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
hepatocellular carcinoma chemoprevention |
Carcinoma Carcinoma, Hepatocellular Liver Cirrhosis Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Fibrosis Pathologic Processes Epigallocatechin gallate Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Neuroprotective Agents |