Clinical trial · Interventional
Erlotinib for Hepatocellular Carcinoma Chemoprevention
Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention
NCT04172779CI-TRIAL-00115718ECHO-Bnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Liver Fibrosis | — | UNRESOLVED | — |
| Cirrhosis, Liver | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erlotinib treatment
- interventionNames
- Drug: erlotinib hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Modulation of serum protein signature associated with hepatocellular carcinoma (HCC) risk
- timeFrame
- Baseline, 24 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.