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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 June 2023 |
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Main ID: |
NCT03289273 |
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Date of registration:
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18/09/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)
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Scientific title:
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REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma |
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Date of first enrolment:
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September 13, 2017 |
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Target sample size:
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1010 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03289273 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Albania
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Algeria
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Argentina
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Austria
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Belgium
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Brazil
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Canada
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China
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Denmark
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Egypt
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France
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Greece
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India
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Italy
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Japan
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Kazakhstan
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Korea, Republic of
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Lebanon
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Luxembourg
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Mexico
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Netherlands
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Oman
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Russian Federation
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Saudi Arabia
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Spain
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Sweden
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Taiwan
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Thailand
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Turkey
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United Arab Emirates
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with confirmed diagnosis of unresectable HCC
- Physician-initiated decision to treat with regorafenib (prior to study enrollment)
Exclusion Criteria:
- Participation in an investigational program with interventions outside of routine
clinical practice
- Past treatment with regorafenib
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Liver Neoplasms
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Intervention(s)
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Drug: Regorafenib (Stivarga, BAY73-4506)
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Primary Outcome(s)
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Number of patients with treatment emergent adverse events (TEAEs) leading to dose modifications (including reductions, interruptions and permanent discontinuation)
[Time Frame: Up to 24 months]
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Secondary Outcome(s)
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Overall survival (OS)
[Time Frame: Up to 24 months]
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Time to progression (TTP)
[Time Frame: Up to 24 months]
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Best overall tumor response (ORR)
[Time Frame: Up to 24 months]
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Duration of regorafenib treatment
[Time Frame: Up to 24 months]
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Progression-free survival (PFS)
[Time Frame: Up to 24 months]
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Secondary ID(s)
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19244
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EUPAS20981
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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