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NCT04172779 · ClinicalTrials.gov registry record · Phase 2
Erlotinib for Hepatocellular Carcinoma Chemoprevention
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Not yet
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT04172779: Clinical Trial Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT04172779 is a Phase 2 study that has not yet begun recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04172779, a Phase 2 study, has not yet begun recruiting, sponsored by University of Texas Southwestern Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG erlotinib hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-12 |
| Est. Completion | 2030-08 |
| Phase | Phase 2 |
What is known before NCT04172779 opens enrollment
NCT04172779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04172779 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04172779 about?
NCT04172779 is a clinical study titled "Erlotinib for Hepatocellular Carcinoma Chemoprevention". 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.
What is the current status of trial NCT04172779?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-12. Estimated completion is 2030-08.
What interventions are being tested in trial NCT04172779?
The interventions under investigation include: Placebo (DRUG), erlotinib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04172779?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04172779's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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