NCT04172779

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
53mo left

Started Aug 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
6.7 years until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

November 17, 2019

Last Update Submit

April 27, 2026

Conditions

Cirrhosis, LiverAdvanced Liver Fibrosis

Keywords

hepatocellular carcinomachemoprevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 24 weeks

Secondary Outcomes (2)

  • Overall adverse event profile for erlotinib hydrochloride

    Baseline, 24 weeks

  • Change in quality of life (QOL)

    Baseline, 24 weeks

Other Outcomes (8)

  • Molecular tissue transcriptome signature associated with HCC risk

    Baseline, 24 weeks

  • Changes in phospho-ERK levels in the liver

    Baseline, 24 weeks

  • Changes in PCNA levels in the liver

    Baseline, 24 weeks

  • +5 more other outcomes

Study Arms (2)

Erlotinib treatment

EXPERIMENTAL
Drug: erlotinib hydrochloride

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

erlotinib hydrochlorideDRUG

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

Erlotinib treatment
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Liver CirrhosisCarcinoma, Hepatocellular

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Yujin Hoshida

    UT Southwestern

    PRINCIPAL INVESTIGATOR

  • Amit Singal, MD, MS

    UT Southwestern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Quirk, MS, MPH

CONTACT

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

Yujin Hoshida, MD, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 17, 2019

First Posted

November 21, 2019

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No IPD will be shared with other researchers.

Locations

US(1)