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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03289273
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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)

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma
Actual Study Start Date : September 13, 2017
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : October 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 :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)



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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


Contacts
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Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

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Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03289273     History of Changes
Other Study ID Numbers: 19244
EUPAS20981 ( Registry Identifier: EMA )
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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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:
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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