Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention
University of Texas Southwestern Medical Center
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Drugerlotinib hydrochloride
Oral administration of erlotinib 50mg (two 25mg capsules)
- DrugPlacebo
Placebo
Location
- UT Southwestern Medical CenterDallas, Texas