Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)
- Registration Number
- NCT03289273
- Lead Sponsor
- Bayer
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1010
- Patients with confirmed diagnosis of unresectable HCC
- Physician-initiated decision to treat with regorafenib (prior to study enrollment)
- Participation in an investigational program with interventions outside of routine clinical practice
- Past treatment with regorafenib
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description uHCC patients treated with regorafenib Regorafenib (Stivarga, BAY73-4506) Patients with a confirmed diagnosis of uHCC and for whom a decision to treat with regorafenib has been made (by the treating physician)
- Primary Outcome Measures
Name Time Method Number of patients with treatment emergent adverse events (TEAEs) leading to dose modifications (including reductions, interruptions and permanent discontinuation) Up to 24 months 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.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Up to 24 months 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
Progression-free survival (PFS) Up to 24 months 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 to progression (TTP) Up to 24 months Time to progression (TTP) is defined as the time (days) from the start of regorafenib treatment to the first documented disease progression
Best overall tumor response (ORR) Up to 24 months Best overall tumor response (ORR) will be defined according to investigator-assessed data according to local standard
Duration of regorafenib treatment Up to 24 months 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)
Trial Locations
- Locations (18)
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Rutgers University
🇺🇸Newark, New Jersey, United States
Corporal Michael J. Crescenz VA Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Louisville - Clinical Trials Unit
🇺🇸Louisville, Kentucky, United States
University of Florida Health
🇺🇸Gainesville, Florida, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
University of Cincinatti
🇺🇸Cincinnati, Ohio, United States
C.R.Wood Cancer Center, Glen Falls Hospital
🇺🇸Glens Falls, New York, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Many locations
🇹🇷Multiple Locations, Turkey
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
University Medical Center
🇺🇸New Orleans, Louisiana, United States
St. Joseph´s Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States