Study on Erlotinib for Preventing Liver Cancer in Patients with Advanced Liver Fibrosis or Cirrhosis

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04172779

Provider View

This clinical trial is testing whether a low dose of the drug erlotinib can safely and effectively prevent liver cancer in patients who have advanced liver fibrosis or cirrhosis.

Patient Parameters

Program Overview

The purpose of this study is to find out if taking a low dose of erlotinib can help prevent the development of liver cancer in people with advanced liver fibrosis or cirrhosis. This is a phase II trial, which means it is focused on assessing the safety and effectiveness of the treatment. Participants will be randomly assigned to receive either erlotinib or a placebo (a substance with no active drug) to compare the outcomes.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Diagnosed with advanced liver fibrosis or cirrhosis, either through clinical evaluation or tissue examination.
  • No current severe liver problems.
  • No previous history of liver cancer.
  • Have a FIB-4 index score greater than 3.25.
  • Have a PLSec score of 3 or higher.
  • Have good blood, liver, and kidney function, and a Karnofsky performance status score of 70 or higher.
  • Open to all genders and racial/ethnic groups.

Exclusion Criteria

  • Have previously been treated with drugs that inhibit the epidermal growth factor receptor (EGFR).
  • Have uncontrolled health issues or are using medications that affect the enzyme CYP3A4.
  • Have taken erlotinib for less than 4 weeks or less than 80% of the planned dose by the end of week 4.
  • Develop liver cancer during the study.

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