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NOT_YET_RECRUITINGPHASE2

Erlotinib for Hepatocellular Carcinoma Chemoprevention

Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention

NCT04172779•University of Texas Southwestern Medical Center

Summary

This phase II randomized placebo-controlled trial studies low-dose erlotinib treatment to assess its efficacy and safety to prevent development of hepatocellular carcinoma in patients with advanced liver fibrosis or cirrhosis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults (≥ 18 years-old)
•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

•Prior treatment with epidermal growth factor receptor (EGFR) inhibitors
•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

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States

Key Dates

Start Date

February 1, 2026

Primary Completion Date

December 1, 2030

Completion Date

December 1, 2030

Last Updated

November 20, 2025

Enrollment

ESTIMATED participants

Conditions

Cirrhosis, LiverAdvanced Liver Fibrosis

Interventions

erlotinib hydrochloride

DRUG

Placebo

DRUG

Contacts

Lisa Quirk, MS, MPH

CONTACT

214-648-3111 Lisa.Quirk@UTSouthwestern.edu

Yujin Hoshida, MD, PhD

CONTACT

214-648-3111 Yujin.Hoshida@UTSouthwestern.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Erlotinib for Hepatocellular Carcinoma Chemoprevention

Inclusion Criteria

Exclusion Criteria

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

Molecular Mechanism of Exercise in Cirrhosis

Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis

Evaluation of Non-Invasive Tests for Metabolic Liver Disease

Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease

Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival