Liver Neoplasms
Conditions
Keywords
Liver cancer, unresectable hepatocellular carcinoma, real-world practice conditions, safety and effectiveness, management and treatment of liver cancer
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)
Interventions
DRUGRegorafenib (Stivarga, BAY73-4506)
As per the treating physicians discretion
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
Countries
Argentina, Austria, Belgium, Canada, China, Denmark, Egypt, France, Greece, Italy, Japan, Netherlands, Russia, Saudi Arabia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United States
Outcome results
None listed