Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2026-02-28
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Erlotinib treatment
erlotinib hydrochloride
Oral administration of erlotinib 50mg (two 25mg capsules)
Placebo
Placebo
Placebo
Interventions
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erlotinib hydrochloride
Oral administration of erlotinib 50mg (two 25mg capsules)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Clinically and/or histologically diagnosed advanced liver fibrosis or cirrhosis
* No active hepatic decompensation
* No prior history of HCC
* FIB-4 index \> 3.25
* PLSec score ≥ 3
* Adequate hematologic, hepatic, and renal function, Karnofsky performance status score ≥70
* Both sexes and all racial/ethnic groups will be considered
Exclusion Criteria
* Uncontrolled intercurrent, use of CYP3A4 modulators
* Erlotinib treatment \<4 weeks or \<80% of planned regimen at the end of week 4
* HCC development during the study
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Yujin Hoshida, MD, PhD
Professor
Principal Investigators
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Yujin Hoshida
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern
Amit Singal, MD, MS
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU-2019-1515
Identifier Type: -
Identifier Source: org_study_id
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