FibroLamellar Carcinoma: an International Registry Study

Not yet recruiting

• Conditions: Fibrolamellar Cancer of the Liver

• Registration Number: NCT05730686
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Study Start: 2023-02-15
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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