FLiCIR: FibroLamellar Carcinoma: an International Registry Study

• Sponsor: Imperial College London (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05730686
• Collaborator: (none)
• Enrollment: 200
• Anticipated Duration (Months): 24.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fibrolamellar Cancer of the Liver	Procedure: Registry of Therapy of patient's diagnosed with FibroLamellar

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: FibroLamellar Carcinoma: an International Registry Study
• Anticipated Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: Feb 28, 2025
• Anticipated Study Completion Date: Feb 28, 2025

Outcome Measures

Primary Outcome Measures

1. To describe the natural history and clinical outcomes of patients with Fibrolamellar carcinoma of the liver [2 years]

   The following data will be outcomes of interest in this study: treatments received including compliance and tolerability, survival (overall and progress free survival), clinicopathological outcomes. Survival outcomes, response rates

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT05730686
• Other Study ID Numbers: 22HH8014
• First Posted: Feb 16, 2023
• Last Update Posted: Feb 16, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Neoplasms

Study Results

No Results Posted as of Feb 16, 2023