Erlotinib for Hepatocellular Carcinoma Chemoprevention

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04172779

Patient View

This phase II trial evaluates the efficacy and safety of low-dose erlotinib in preventing hepatocellular carcinoma in adults with advanced liver fibrosis or cirrhosis. Participants must have a FIB-4 index > 3.25, PLSec score ≥ 3, and adequate organ function. The study involves oral administration of erlotinib 50mg or placebo, with eligibility open to all sexes and racial/ethnic groups.

Patient Parameters

Program Overview

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

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