UnknownNot Applicable

FibroLamellar Carcinoma: an International Registry Study

200 participantsStarted 2023-02-15

Plain-language summary

Fibrolamellar Hepatocellular Carcinoma (FLC) is a rare (0.05 per 100,000) subtype of primary liver cancer which predominantly affects younger patients, median age of diagnosis 22-23 years. In patients with advanced stage disease the prognosis is poor, and even with aggressive surgery the 5 year survival is less than 50%. Due to the very low incidence of FLC clinical trials are limited, and as these patients are excluded from most clinical trials there is a lack of consensus on the optimal systemic therapy to employ in this population group. There are a number of chemotherapy compounds that have been investigated although these are single-institutional case series and/or registry-based studies. The majority of published registry studies are based in the United States hence it is important to describe the patterns of treatment in Europe which has different regulatory approvals for access to therapeutics. Our aim is to run a European multisite registry study detailing the clinical course of \>100 patients with FLC that have received systemic therapy.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologic confirmed diagnosis of FLC * Written informed consent will be required for the prospective cohort * Adults of \>18 years of age Exclusion Criteria: * Any non- histologic confirmed diagnosis of FLC * Participants with insufficient clinical/ follow up data

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To describe the natural history and clinical outcomes of patients with Fibrolamellar carcinoma of the liver

Timeframe: 2 years

Trial details

NCT IDNCT05730686

SponsorImperial College London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-02-28

View on ClinicalTrials.gov More Fibrolamellar Cancer of the Liver trials