Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC) Oral
Public ClinicalTrials.gov record NCT04025567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase II Study of Oral Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: Fibrolamellar Hepatocellular Carcinoma (FLC) is a rare liver cancer. It most often occurs in young people who have no history of liver disease. Unresectable FLC most often does not improve with surgery. Researchers think gut bacteria may affect liver cancer control. They want to see if a drug that controls a type of bacteria can help. Objective: To test if vancomycin is safe and tolerable for and can treat people with unresectable FLC. Eligibility: People ages 18 and older with FLC that isn t responsive to treatment Design: Participants will be screened with a medical history, physical exam, blood and urine tests, and CT or MRI scans. They will provide a tumor sample: If they do not have one, they will have a biopsy. Participants will take vancomycin 3 times a day. They will take the drug by mouth. They will take the drug in 28-day cycles. They will take the drug daily for the first 3 weeks. They will not take the drug the last week. Participants will keep a medication diary. Participants will have blood and urine tests each cycle. They may provide stool samples. Participants will have a biopsy before they start treatment. Then they will have one on day 1 of cycle 2. Participants will have scans on day 1 of cycle 2. Then they will have scans about every 8 weeks. Participants will continue treatment until their cancer gets worse or they can no longer tolerate the side effects. Participants will have a follow-up visit about a month after they finish treatment. Then they will be followed every 6 months by phone or email.
Study identification
- NCT ID
- NCT04025567
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 11, 2020
- Primary completion
- Dec 30, 2021
- Completion
- Dec 30, 2021
- Last update posted
- Mar 15, 2020
2020 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04025567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2020 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04025567 live on ClinicalTrials.gov.