Erlotinib for Hepatocellular Carcinoma Chemoprevention

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04172779

Acronym

ECHO-B

Enrollment

Registered

2019-11-21

Start date

2026-12-01

Completion date

2030-08-01

Last updated

2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Liver Fibrosis, Cirrhosis, Liver

Keywords

hepatocellular carcinoma, chemoprevention

Brief 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.

Interventions

DRUGerlotinib hydrochloride

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

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Modulation of serum protein signature associated with hepatocellular carcinoma (HCC) risk	Baseline, 24 weeks	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.

Secondary

Measure	Time frame	Description
Overall adverse event profile for erlotinib hydrochloride	Baseline, 24 weeks	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.
Change in quality of life (QOL)	Baseline, 24 weeks	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.

Countries

United States

Contacts

CONTACTLisa Quirk, MS, MPH

Lisa.Quirk@UTSouthwestern.edu214-648-3111

CONTACTYujin Hoshida, MD, PhD

Yujin.Hoshida@UTSouthwestern.edu214-648-3111

PRINCIPAL_INVESTIGATORYujin Hoshida

UT Southwestern

PRINCIPAL_INVESTIGATORAmit Singal, MD, MS