Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)
Study Type
OBSERVATIONAL
Enrollment
1,010
As per the treating physicians discretion
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.
Time frame: Up to 24 months
Overall survival (OS)
Overall survival (OS) is defined as the time (days) from the start of regorafenib treatment to the date of death, due to any reason. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up
Time frame: Up to 24 months
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time (days) from the start of regorafenib treatment to the date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented
Time frame: Up to 24 months
Time to progression (TTP)
Time to progression (TTP) is defined as the time (days) from the start of regorafenib treatment to the first documented disease progression
Time frame: Up to 24 months
Best overall tumor response (ORR)
Best overall tumor response (ORR) will be defined according to investigator-assessed data according to local standard
Time frame: Up to 24 months
Duration of regorafenib treatment
Duration of regorafenib treatment, defined by the time interval from the start of regorafenib treatment to the day of permanent discontinuation of regorafenib (including death)
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
St. Joseph´s Hospital and Medical Center
Phoenix, Arizona, United States
University of Florida Health
Gainesville, Florida, United States
University of Louisville - Clinical Trials Unit
Louisville, Kentucky, United States
University Medical Center
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Rutgers University
Newark, New Jersey, United States
...and 27 more locations
Time frame: Up to 24 months