Observational Study of Lenvatinib for Hepatocellular Carcinoma
Research type
Research Study
Full title
A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients with Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)
IRAS ID
289462
Contact name
Tim Meyer
Contact email
Sponsor organisation
Eisai Ltd
Duration of Study in the UK
8 years, 5 months, 6 days
Research summary
Hepatocellular carcinoma (HCC) is the most common type of liver cancer and is one of the fastest rising cause of cancer-related mortality. Patients with advanced or inoperable HCC that is not treatable with surgery or local treatment have few effective treatment options.
This study is an open-label phase 4 Post-authorisation Safety Study (PASS) where data will be collected from patients for whom a decision has been made by the treating physician to initiate lenvatinib or sorafenib as their standard or care treatment. No additional medication or procedures will be involved.
The purpose of this observational study is to further characterise the safety of lenvatinib, primarily liver effects, in patients with HCC for whom the decision to treat with lenvatinib has been made as part of routine clinical practice. Data for patients treated with sorafenib will also be collected to provide context.
Data on treatment with lenvatinib or sorafenib will be collected during visits that occur within routine clinical practice. Historical patient data will also be sourced from medical records. The following data will be collected: study eligibility, dates of clinic visits, patient demographics, medical history, concomitant medications, liver function, cancer treatments, treatment patterns, survival, and safety events of interest, including (but not limited to) toxicities of the liver and impairment of the kidneys.
Approximately 500 lenvatinib and 500 sorafenib patients will participate in this study worldwide, with at least 155 of these in Europe for each treatment arm.
Eisai is the Sponsor and marketing authorisation holder for lenvatinib.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
20/PR/1009
Date of REC Opinion
26 Jan 2021
REC opinion
Further Information Favourable Opinion