Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)

Liver Neoplasms Clinical Trial

Official title:

REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289273
• Other study ID #: 19244
• Secondary ID: EUPAS20981
• Status: Completed
• Start date: September 13, 2017
• Est. completion date: June 21, 2022

Study information

• Verified date: June 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1010
• Est. completion date: June 21, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

Drug:
• Regorafenib (Stivarga, BAY73-4506)
As per the treating physicians discretion

Locations

Country	Name	City	State
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
Korea, Republic of	Many locations	Multiple Locations
Netherlands	Many locations	Multiple Locations
Russian Federation	Many locations	Multiple Locations
Saudi Arabia	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	Many locations	Multiple Locations
United States	University of Michigan	Ann Arbor	Michigan
United States	Mercy Medical Center	Baltimore	Maryland
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of Cincinatti	Cincinnati	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Florida Health	Gainesville	Florida
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	C.R.Wood Cancer Center, Glen Falls Hospital	Glens Falls	New York
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Louisville - Clinical Trials Unit	Louisville	Kentucky
United States	University Medical Center	New Orleans	Louisiana
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	St. Joseph´s Hospital and Medical Center	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Canada,  China,  Denmark,  Egypt,  France,  Greece,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Russian Federation,  Saudi Arabia,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Up to 24 months
Secondary	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	Up to 24 months
Secondary	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	Up to 24 months
Secondary	Best overall tumor response (ORR)	Best overall tumor response (ORR) will be defined according to investigator-assessed data according to local standard	Up to 24 months
Secondary	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)	Up to 24 months

External Links

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