Clinical trial NCT03289273: Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)
Official title: REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Neoplasms
Keywords: Liver cancer
unresectable hepatocellular carcinoma
real-world practice conditions
safety and effectiveness
management and treatment of liver cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-09-20
Enrollment: 1010
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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)


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with treatment emergent adverse events (TEAEs) leading to dose modifications (including reductions, interruptions and permanent discontinuation)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 24 months
measure: Progression-free survival (PFS)
timeFrame: Up to 24 months
measure: Time to progression (TTP)
timeFrame: Up to 24 months
measure: Best overall tumor response (ORR)
timeFrame: Up to 24 months
measure: Duration of regorafenib treatment
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph´s Hospital and Medical Center
state: Arizona
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Louisville
country: United States
facility: University of Louisville - Clinical Trials Unit
state: Kentucky
city: New Orleans
country: United States
facility: University Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Newark
country: United States
facility: Rutgers University
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Glens Falls
country: United States
facility: C.R.Wood Cancer Center, Glen Falls Hospital
state: New York
city: Cincinnati
country: United States
facility: University of Cincinatti
state: Ohio
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Multiple Locations
country: Argentina
facility: Many locations
city: Multiple Locations
country: Austria
facility: Many locations
city: Multiple Locations
country: Belgium
facility: Many locations
city: Multiple Locations
country: Canada
facility: Many locations
city: Multiple Locations
country: China
facility: Many locations
city: Multiple Locations
country: Denmark
facility: Many locations
city: Multiple Locations
country: Egypt
facility: Many locations
city: Multiple Locations
country: France
facility: Many locations
city: Multiple Locations
country: Greece
facility: Many locations
city: Multiple Locations
country: Italy
facility: Many locations
city: Multiple Locations
country: Japan
facility: Many locations
city: Multiple Locations
country: Korea, Republic of
facility: Many locations
city: Multiple Locations
country: Netherlands
facility: Many locations
city: Multiple Locations
country: Russian Federation
facility: Many locations
city: Multiple Locations
country: Saudi Arabia
facility: Many locations
city: Multiple Locations
country: Spain
facility: Many locations
city: Multiple Locations
country: Sweden
facility: Many locations
city: Multiple Locations
country: Taiwan
facility: Many locations
city: Multiple Locations
country: Thailand
facility: Many locations
city: Multiple Locations
country: Turkey
facility: Many locations
Study officials:
References: