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Use of Sorafenib and/or Regorafenib in Liver Cancer (Hepatocellular Carcinoma) Subsequent to Another Systemic First-line Treatment (SORAGO-HCC)

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: NCT03644511
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

Researchers already did trials that showed Sorafenib and Regorafenib worked for patients with hepatocellular carcinoma (most common liver tumor type).

In this trial, they want to learn more about the same patient group in which Sorafenib or Regorafenib is given after other drugs. Patients participating in this study will be observed until 12 months after the last patient has been enrolled to collect data on how safe the drugs are and how well they are working when used as second line or beyond treatment.


Condition or disease Intervention/treatment
Hepatocellular Carcinoma Drug: Regorafenib (Stivarga, BAY73-4506) Drug: Sorafenib (Nexavar, BAY43-9006)

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Sorafenib and/or Regorafenib in Hepatocellular Carcinoma (HCC) Subsequent to Another Systemic First-line Treatment
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with HCC
Treated with Nexavar and/or Stivarga as ≥ 2nd-line systemic treatment
Drug: Regorafenib (Stivarga, BAY73-4506)
Prescribed by physician.

Drug: Sorafenib (Nexavar, BAY43-9006)
Prescribed by physician.




Primary Outcome Measures :
  1. Identification of current treatment patterns by means of individual treatment lines in the systemic HCC therapy with regards to Nexavar and Stivarga, i.e. when both drugs are used in ≥ 2nd-line under current practice conditions [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapy [ Time Frame: Up to 36 months ]
  2. Progression free survival (PFS) [ Time Frame: Up to 36 months ]
  3. Time to progression (TTP) [ Time Frame: Up to 36 months ]
  4. Duration of Nexavar or Stivarga treatment [ Time Frame: Up to 36 months ]
  5. Tumor response to treatment [ Time Frame: Up to 36 months ]
    Evaluated by the investigator according to the categories "complete response", "partial response", "stable disease", "progressive disease by clinical judgment", "progressive disease measurement proven", "unknown" and "not applicable", and will be analyzed providing absolute and relative frequencies of the tumor status categories.

  6. Incidence of treatment-emergent adverse events (TEAE) [ Time Frame: Up to 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of patients with HCC in stage BCLC-B (Barcelona Classification of Liver Cancer) or BCLC-C for whom the decision to treat with Nexavar and/or Stivarga as ≥ 2nd-line has been taken by the investigator and the drugs are prescribed in the customary manner in accordance with the terms of the marketing authorization.
Criteria

Inclusion Criteria:

  • Diagnosis of hepatocellular cancer in stage BCLC-B or BCLC-C
  • Decision to initiate treatment with Nexavar (sorafenib) and/or Stivarga (regorafenib) as 2nd-line or beyond treatment was made as per investigator's routine treatment practice. Stivarga (regorafenib) must be used according to its indication, i.e. after prior progression under Nexavar (sorafenib) treatment.

Exclusion Criteria:

  • Patients concurrently participating in an investigational program for the treatment of HCC with interventions outside of routine clinical practice.
  • Stivarga (regorafenib) treatment without prior therapy with Nexavar (sorafenib). NOTE: Nexavar (sorafenib) treatment could have been given as treatment for HCC outside of this non-interventional study. In this case Stivarga (regorafenib) would NOT constitute the second-line therapy after direct pretreatment with Nexavar (sorafenib) but e.g. 3rd-line treatment directly after a different drug.
  • Contra-indications according to the local marketing authorization.

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): NCT03644511


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Germany
Many Locations Recruiting
Multiple Locations, Germany
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03644511     History of Changes
Other Study ID Numbers: 20215
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


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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:
HCC
Liver cancer
Live cell carcinoma

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action