Clinical trial · Interventional
EGCG for Hepatocellular Carcinoma Chemoprevention
Phase II Randomized Controlled Trial of Epigallocatechin Gallate for Hepatocellular Carcinoma Chemoprevention
NCT06015022CI-TRIAL-00094594CATCH-BrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis, Liver | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epigallocatechin gallate (EGCG) | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Epigallocatechin gallate 600 - 800mg
- description
- 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.
- interventionNames
- Drug: Epigallocatechin gallate (EGCG)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Oral administration of placebo for 24 weeks
- interventionNames
- Other: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.