Erlotinib for Hepatocellular Carcinoma Chemoprevention (ECHO-B)

The University of Texas System (UT)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Cirrhosis, Liver; Advanced Liver Fibrosis

Treatments: Drug: Placebo; Drug: erlotinib hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04172779

STU-2019-1515

P50CA295495 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

Erlotinib treatment

Experimental group

Treatment:

Drug: erlotinib hydrochloride

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo