NCT04172779Not yet recruitingPhase 2
Erlotinib for Hepatocellular Carcinoma Chemoprevention
Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 17 Nov 2019
- Start date
- Dec 2026
- Primary completion date
- Jun 2030
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04172779
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From Dec 2026 to the primary completion date, Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Prior treatment with epidermal growth factor receptor (EGFR) inhibitors
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.