Erlotinib for Hepatocellular Carcinoma Chemoprevention

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

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.

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