FibroLamellar Carcinoma: an International Registry Study (FLiCIR)

Imperial College London

Status: Not yet enrolling

Conditions: Fibrolamellar Cancer of the Liver

Treatments: Procedure: Registry of Therapy of patient's diagnosed with FibroLamellar

Study type: Observational

Funder types: Other

Identifiers

NCT05730686

22HH8014

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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