Erlotinib for Hepatocellular Carcinoma Chemoprevention

Phase 2Not Yet RecruitingNCT04172779

University of Texas Southwestern Medical Center60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Cirrhosis, Liver Advanced Liver Fibrosis

Interventions

erlotinib hydrochlorideDRUG

Oral administration of erlotinib 50mg (two 25mg capsules)

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Modulation of serum protein signature associated with hepatocellular carcinoma (HCC) risk

The relationship between the treatment and modulation of a serum protein signature associated with HCC risk (PLSec) will be assessed. PLSec-based HCC risk level (i.e., PLSec score) will be compared between baseline and at the end of treatment, and magnitude of the modulation will be measured as delta-PLSec and compared between the treatment groups by t-test and Wilcoxon rank-sum test.

Time frame: Baseline, 24 weeks

Secondary Outcomes

Overall adverse event profile for erlotinib hydrochloride

Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5. The maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number and severity of adverse events will be tabulated and summarized across all grades. Grade 3+ adverse events will be similarly described and summarized separately. Overall toxicity incidence, as well as toxicity profiles will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.

Time frame: Baseline, 24 weeks

Change in quality of life (QOL)

QOL will be measured by using Chronic Liver Disease Questionnaire (CLDQ), and compared between baseline and end of the treatment. Frequency distributions, graphical techniques and other descriptive measures will be used to summarize the results. Paired t-test will be used to assess change of the measurements.

Time frame: Baseline, 24 weeks

Central Contacts

Lisa Quirk, MS, MPH

CONTACT

214-648-3111 Lisa.Quirk@UTSouthwestern.edu

Yujin Hoshida, MD, PhD

CONTACT

214-648-3111 Yujin.Hoshida@UTSouthwestern.edu

Data from ClinicalTrials.gov

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