Erlotinib for Hepatocellular Carcinoma Chemoprevention

The University of Texas System (UT)

Status and phase: Begins enrollment in 5 months; Phase 2

Conditions: Cirrhosis, Liver

Treatments: Drug: Erlotinib Hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04172779

STU-2019-1515

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Erlotinib treatment

Experimental group

Treatment:

Drug: Erlotinib Hydrochloride