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Erlotinib for Hepatocellular Carcinoma Chemoprevention

The University of Texas System (UT) logo

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)

30 participants in 1 patient group

Erlotinib treatment
Experimental group
Treatment:
Drug: Erlotinib Hydrochloride

Trial contacts and locations

0

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Central trial contact

Yujin Hoshida, MD, PhD; Amit Singal, MD, MS

Data sourced from clinicaltrials.gov

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