Cirrhosis, LiverPhase 2ECHO-BNCT04172779
Erlotinib for Hepatocellular Carcinoma Chemoprevention
A Phase 2 study testing erlotinib hydrochloride in people with Cirrhosis, Liver and Advanced Liver Fibrosis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Advanced Liver Fibrosis
- What is being tested?
- erlotinib hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390
Yujin Hoshida, 2146486137, yujin.hoshida@utsouthwestern.edu
About this study
Official title: Phase II Clinical Trial of Low-dose 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.
- Conditions
- Cirrhosis, Liver, Advanced Liver Fibrosis
- Being tested
- erlotinib hydrochloride, Placebo
- Keywords
- hepatocellular carcinoma, chemoprevention
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
Oral administration of erlotinib 50mg (two 25mg capsules)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib treatment | Experimental | Not described Receives: Drug: erlotinib hydrochloride |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation of serum protein signature associated with hepatocellular carcinoma (HCC) risk
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.
Measured: Baseline, 24 weeks
Secondary outcomes (2)
Overall adverse event profile for erlotinib hydrochloride
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.
Measured: Baseline, 24 weeks
Change in quality of life (QOL)
QOL will be measured by using Chronic Liver Disease Questionnaire (CLDQ), 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.
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study startDec 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Yujin Hoshida, MD, PhD, University of Texas Southwestern Medical Center
- Investigators
- Yujin Hoshida, Principal investigator, UT SouthwesternAmit Singal, MD, MS, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172779
- Sponsor's protocol ID
- STU-2019-1515
- Other IDs
- P50CA295495
- Acronym
- ECHO-B
- Status last verified
- Jun 2026
- First submitted
- 17 Nov 2019
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention
- ClinicalTrials.gov ID
- NCT04172779
- Acronym / sponsor ID
- ECHO-B / STU-2019-1515
- Conditions
- Cirrhosis, Liver, Advanced Liver Fibrosis
- Keywords
- hepatocellular carcinoma, chemoprevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib treatment | Experimental | Drug: erlotinib hydrochloride |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erlotinib hydrochlorideOral administration of erlotinib 50mg (two 25mg capsules) | Drug | Erlotinib treatment |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Modulation of serum protein signature associated with hepatocellular carcinoma (HCC) risk
Time frame: Baseline, 24 weeks
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.
2 secondary outcomes
Overall adverse event profile for erlotinib hydrochloride
Time frame: Baseline, 24 weeks
Change in quality of life (QOL)
Time frame: Baseline, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yujin Hoshida principal investigator
UT Southwestern
Amit Singal, MD, MS principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing erlotinib hydrochloride in people with Cirrhosis, Liver and Advanced Liver Fibrosis, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Quirk, MS, MPH (214-648-3111, Lisa.Quirk@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modulation of serum protein signature associated with hepatocellular carcinoma (HCC) risk (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.