Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03289273 |
|
Recruitment Status :
Active, not recruiting
First Posted : September 20, 2017
Last Update Posted : April 28, 2022
|
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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)
| Condition or disease | Intervention/treatment |
|---|---|
| Liver Neoplasms | Drug: Regorafenib (Stivarga, BAY73-4506) |
| Study Type : | Observational |
| Actual Enrollment : | 1010 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma |
| Actual Study Start Date : | September 13, 2017 |
| Actual Primary Completion Date : | January 31, 2022 |
| Estimated Study Completion Date : | June 1, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Liver Cancer
Drug Information available for:
Regorafenib
| Group/Cohort | Intervention/treatment |
|---|---|
|
uHCC patients treated with regorafenib
Patients with a confirmed diagnosis of uHCC and for whom a decision to treat with regorafenib has been made (by the treating physician)
|
Drug: Regorafenib (Stivarga, BAY73-4506)
As per the treating physicians discretion |
Primary Outcome Measures :
- Number of patients with treatment emergent adverse events (TEAEs) leading to dose modifications (including reductions, interruptions and permanent discontinuation) [ Time Frame: 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 :
- Overall survival (OS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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)
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289273
Locations
Show 37 study locations
Sponsors and Collaborators
Bayer
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT03289273 |
| Other Study ID Numbers: |
19244 EUPAS20981 ( Registry Identifier: EMA ) |
| First Posted: | September 20, 2017 Key Record Dates |
| Last Update Posted: | April 28, 2022 |
| Last Verified: | April 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bayer:
|
Liver cancer unresectable hepatocellular carcinoma real-world practice conditions safety and effectiveness management and treatment of liver cancer |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Liver Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Adenocarcinoma Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |