Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)
REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma
2 other identifiers
observational
1,010
21 countries
37
Brief Summary
Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Longer than P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 13, 2017
CompletedFirst Submitted
Initial submission to the registry
September 18, 2017
CompletedFirst Posted
Study publicly available on registry
September 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2022
CompletedJune 13, 2023
June 1, 2023
4.4 years
September 18, 2017
June 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with treatment emergent adverse events (TEAEs) leading to dose modifications (including reductions, interruptions and permanent discontinuation)
The primary endpoint is the safety of regorafenib in patients with uHCC, defined as the frequency of documented TEAEs, including serious adverse events (SAEs). Safety will be assessed in all patients who receive at least one dose of regorafenib regardless of prior treatment.
Up to 24 months
Secondary Outcomes (5)
Overall survival (OS)
Up to 24 months
Progression-free survival (PFS)
Up to 24 months
Time to progression (TTP)
Up to 24 months
Best overall tumor response (ORR)
Up to 24 months
Duration of regorafenib treatment
Up to 24 months
Study Arms (1)
uHCC patients treated with regorafenib
Patients with a confirmed diagnosis of uHCC and for whom a decision to treat with regorafenib has been made (by the treating physician)
Interventions
As per the treating physicians discretion
Eligibility Criteria
Source population of the study are patients with unresectable hepatocellular carcinoma. Patients with this condition are mostly managed at specialist centers and cancer hospitals. The participation of these specialized centers in the study is going to ensure the representativeness of the study population. Physicians will be asked to sample consecutive patients whenever possible to avoid selection bias and thus increase the likelihood of representativeness.
You may qualify if:
- Patients with confirmed diagnosis of unresectable HCC
- Physician-initiated decision to treat with regorafenib (prior to study enrollment)
You may not qualify if:
- Participation in an investigational program with interventions outside of routine clinical practice
- Past treatment with regorafenib
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (37)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
St. Joseph´s Hospital and Medical Center
Phoenix, Arizona, 85013, United States
University of Florida Health
Gainesville, Florida, 32610, United States
University of Louisville - Clinical Trials Unit
Louisville, Kentucky, 40202, United States
University Medical Center
New Orleans, Louisiana, 70112, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Rutgers University
Newark, New Jersey, 07101-1709, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
C.R.Wood Cancer Center, Glen Falls Hospital
Glens Falls, New York, 12801, United States
University of Cincinatti
Cincinnati, Ohio, 45267, United States
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Many locations
Multiple Locations, Argentina
Many locations
Multiple Locations, Austria
Many locations
Multiple Locations, Belgium
Many locations
Multiple Locations, Canada
Many locations
Multiple Locations, China
Many locations
Multiple Locations, Denmark
Many locations
Multiple Locations, Egypt
Many locations
Multiple Locations, France
Many locations
Multiple Locations, Greece
Many locations
Multiple Locations, Italy
Many locations
Multiple Locations, Japan
Many locations
Multiple Locations, Netherlands
Many locations
Multiple Locations, Russia
Many locations
Multiple Locations, Saudi Arabia
Many locations
Multiple Locations, South Korea
Many locations
Multiple Locations, Spain
Many locations
Multiple Locations, Sweden
Many locations
Multiple Locations, Taiwan
Many locations
Multiple Locations, Thailand
Many locations
Multiple Locations, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2017
First Posted
September 20, 2017
Study Start
September 13, 2017
Primary Completion
January 31, 2022
Study Completion
June 21, 2022
Last Updated
June 13, 2023
Record last verified: 2023-06