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

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Regorafenib (Stivarga, BAY73-4506); Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT03644511
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-23
• Study Start: 2019-01-24
• Primary Completion: 2019-07-18
• Study Completion: 2019-09-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with HCC	Regorafenib (Stivarga, BAY73-4506)	Treated with Nexavar and/or Stivarga as ≥ 2nd-line systemic treatment
Patients with HCC	Sorafenib (Nexavar, BAY43-9006)	Treated with Nexavar and/or Stivarga as ≥ 2nd-line systemic treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Up to 36 months
Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapy	Up to 36 months
Incidence of treatment-emergent adverse events (TEAE)	Up to 36 months
Time to progression (TTP)	Up to 36 months
Duration of Nexavar or Stivarga treatment	Up to 36 months
Tumor response to treatment	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.

Trial Locations

Locations (1)

Many Locations; 🇩🇪 Multiple Locations, Germany