Use of Sorafenib and/or Regorafenib in Liver Cancer (Hepatocellular Carcinoma) Subsequent to Another Systemic First-line Treatment (SORAGO-HCC)
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|ClinicalTrials.gov Identifier: NCT03644511|
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : August 13, 2019
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)|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
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.
- 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 ]
- Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapy [ Time Frame: Up to 36 months ]
- Progression free survival (PFS) [ Time Frame: Up to 36 months ]
- Time to progression (TTP) [ Time Frame: Up to 36 months ]
- Duration of Nexavar or Stivarga treatment [ Time Frame: Up to 36 months ]
- 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.
- Incidence of treatment-emergent adverse events (TEAE) [ Time Frame: Up to 36 months ]
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
|Contact: Bayer Clinical Trials Contact||(+)1-888-84 email@example.com|
|Multiple Locations, Germany|