Erlotinib for Hepatocellular Carcinoma Chemoprevention

Phase 2

Not yet recruiting

• Conditions: Cirrhosis, Liver
• Interventions: Drug: Erlotinib Hydrochloride

• Registration Number: NCT04172779
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

This phase IIa trial studies long-term low-dose erlotinib hydrochloride treatment to assess its efficacy and safety to prevent development of hepatocellular carcinoma in patients with liver cirrhosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-17
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Study Start: 2025-07
• Primary Completion: 2030-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adults (≥ 18 years-old)
• Clinically and/or histologically diagnosed cirrhosis
• No active hepatic decompensation
• No prior history of HCC
• Adequate hematologic, hepatic, and renal function, Karnofsky performance status score ≥70
• Both sexes and all racial/ethnic groups will be considered

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Exclusion Criteria

• Prior treatment with epidermal growth factor receptor (EGFR) inhibitors
• Uncontrolled intercurrent, use of CYP3A4 modulators
• Failed biopsy
• Erlotinib treatment <4 weeks or <80% of planned regimen at the end of week 4
• HCC development during the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erlotinib treatment	Erlotinib Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Modulation of gene expression signatures associated with hepatocellular carcinoma (HCC) risk	Baseline to week 48	The relationship between the treatment and modulation of a gene expression signature associated with HCC risk will be assessed. Expression levels of the signature genes will be compared between baseline and at the end of treatment, and magnitude of the modulation will be measured by Kolmogorov-Smirnov statistic-based Combined Enrichment Score (CES) and tested for significance by using one-sample t-test.

Secondary Outcome Measures

Name	Time	Method
Overall adverse event profile for erlotinib hydrochloride	Baseline to week 48	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 to week 48	QOL will be measured by using the SF-12v2 health survey questionnaire, 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.