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

Hepatocellular Carcinoma Clinical Trial

— SORAGO-HCC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03644511
• Other study ID #: 20215
• Status: Terminated
• Start date: January 24, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: August 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 30, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Regorafenib (Stivarga, BAY73-4506)
Prescribed by physician.
• Sorafenib (Nexavar, BAY43-9006)
Prescribed by physician.

Locations

Country	Name	City	State
Germany	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Up to 24 months
Secondary	Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapy		Up to 36 months
Secondary	Progression free survival (PFS)		Up to 36 months
Secondary	Time to progression (TTP)		Up to 36 months
Secondary	Duration of Nexavar or Stivarga treatment		Up to 36 months
Secondary	Tumor response to treatment	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.	Up to 36 months
Secondary	Incidence of treatment-emergent adverse events (TEAE)		Up to 36 months

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