Erlotinib for Hepatocellular Carcinoma Chemoprevention
Part of paid clinical trials in Dallas, Texas.
- Sponsor
- University of Texas Southwestern Medical Center
- Study ID
- NCT04172779
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Advanced Liver Fibrosis
- Cirrhosis, Liver
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- erlotinib hydrochloride — DRUGOral administration of erlotinib 50mg (two 25mg capsules)
- Placebo — DRUGPlacebo
Study Details
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.
Key Dates
- Start date
- Aug 31, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2030
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Erlotinib treatment
- Placebo Comparator: Placebo
Primary Outcome Measure
Modulation of serum protein signature associated with hepatocellular carcinoma (HCC) risk [ Time Frame: Baseline, 24 weeks ]
Central Contacts
- Lisa Quirk, MS, MPH214-648-3111
- Yujin Hoshida, MD, PhD214-648-3111
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 |
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