Erlotinib for Hepatocellular Carcinoma Chemoprevention
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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
Qualifiers
Adults (≥ 18 years-old)
Clinically and/or histologically diagnosed advanced liver fibrosis or cirrhosis
No active hepatic decompensation
No prior history of HCC
Disqualifiers
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
Trial design
Treatments tested in this trial
- erlotinib hydrochloride
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Texas Southwestern Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov