Tests erlotinib to help prevent liver cancer in people with cirrhosis
Tests low-dose erlotinib against placebo in adults with advanced liver scarring or cirrhosis.
Key facts
- Who runs it
- University of Texas Southwestern Medical Center
- Where
- Dallas, United StatesSee the site
- Trial code
- Registry title
- Erlotinib for Hepatocellular Carcinoma Chemoprevention
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 60 people, planned
- Starts
- Dec 2026
- Expected to end
- Aug 2030
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- erlotinib hydrochloride
- Placebo
- Record updated
- 24 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced liver fibrosis or cirrhosis who have never had liver cancer. It tests low-dose erlotinib against a placebo to see if it helps prevent liver cancer.
- Age
- 18 years or older
- Sex
- Men and women can both join.
- Disease stage
- Advanced liver fibrosis or cirrhosis, diagnosed by a doctor and/or by tissue test. No active hepatic decompensation.
- Earlier treatment
- People who had treatment with EGFR inhibitors before cannot join.
- Biomarker or test result
- FIB-4 index above 3.25 and PLSec score of 3 or higher.
Main reasons for not taking part
- Prior history of hepatocellular carcinoma (HCC)
- Prior treatment with epidermal growth factor receptor (EGFR) inhibitors
- Active hepatic decompensation
- Uncontrolled intercurrent illness or use of CYP3A4 modulators
- Poor blood, liver or kidney function
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
- UT Southwestern Medical CenterDallas, United StatesContact: Yujin HoshidaNot yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Erlotinib treatmentTreatment being tested
Treatment: erlotinib hydrochloride
- PlaceboPlacebo, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention
- Plain-language title
- Tests erlotinib to help prevent liver cancer in people with cirrhosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 24 June 2026