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Not yet recruiting NCT04172779

Erlotinib for Hepatocellular Carcinoma Chemoprevention

Phase II Interventional Cirrhosis, Liver Advanced Liver Fibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: erlotinib hydrochloride, Placebo.
Who it may be relevant to
Registry conditions: Cirrhosis, Liver, Advanced Liver Fibrosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention

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.

Interventions

  • Drug erlotinib hydrochloride
    Oral administration of erlotinib 50mg (two 25mg capsules)
  • Drug Placebo
    Placebo

Primary outcome measures

  • Modulation of serum protein signature associated with hepatocellular carcinoma (HCC) risk [Time frame: Baseline, 24 weeks]
Secondary outcome measures (2)
  • Overall adverse event profile for erlotinib hydrochloride [Time frame: Baseline, 24 weeks]
  • Change in quality of life (QOL) [Time frame: Baseline, 24 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • UT Southwestern Medical Center — Dallas

Identifiers

NCT: NCT04172779 · STU-2019-1515 · P50CA295495

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗