Trial Condition(s):
Liver neoplasms
Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)
Bayer Identifier:
19244
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Mercy Medical Center Baltimore, United States, 21202 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Japan | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, France | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Italy | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Spain | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Sweden | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Denmark | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Argentina | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Austria | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Turkey | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Russia | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, China | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, South Korea | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Thailand | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Egypt | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Saudi Arabia | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Greece | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Henry Ford Health System Detroit, United States, 48202 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Belgium | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Netherlands | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Einstein Medical Center Philadelphia, United States, 19141 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Joseph´s Hospital and Medical Center Phoenix, United States, 85013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Florida Health Gainsville, United States, 32610 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Corporal Michael J. Crescenz VA Medical Center Philadelphia, United States, 19104 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Michigan Ann Arbor, United States, 48109 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University Medical Center New Orleans, United States, 70112 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UT Southwestern Medical Center Dallas, United States, 75390 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Louisville - Clinical Trials Unit Louisville, United States, 40202 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Canada | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rutgers University Newark, United States, 07101-1709 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mayo Clinic Rochester, United States, 55905 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Cincinatti Cincinatti, United States, 45267 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Banner MD Anderson Cancer Center Gilbert, United States, 85234 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations C.R.Wood Cancer Center, Glen Falls Hospital Glen Falls, United States, 12801 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Roswell Park Cancer Institute Buffalo, United States, 14263 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MD Anderson Cancer Center Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
REFINE: Regorafenib observational study in hepatocellular carcinoma
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 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.Timeframe: Up to 24 months
Secondary Outcome
- 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-upTimeframe: 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 documentedTimeframe: 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 progressionTimeframe: 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 standardTimeframe: Up to 24 months
- Duration of regorafenib treatmentDuration of regorafenib treatment, defined by the time interval from the start of regorafenib treatment to the day of permanent discontinuation of regorafenib (including death)Timeframe: Up to 24 months
Additional Information
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