Erlotinib for Hepatocellular Carcinoma Chemoprevention

• Status: Not yet recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase IIa trial studies long-term low-dose erlotinib hydrochloride treatment to assess its efficacy and safety to prevent development of hepatocellular carcinoma in patients with liver cirrhosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Erlotinib Hydrochloride

Criteria

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

Exclusion Criteria:

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

• Uncontrolled intercurrent, use of CYP3A4 modulators

• Failed biopsy

• Erlotinib treatment <4 weeks or <80% of planned regimen at the end of week 4

• HCC development during the study