Erlotinib for Hepatocellular Carcinoma Chemoprevention

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Cirrhosis, Liver, Advanced Liver Fibrosis

In brief

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.

Key facts

Study ID

NCT04172779

Run by

University of Texas Southwestern Medical Center

People needed

60

Starts

2026-12-01

Expected to finish

2030-08-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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