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

NCT ID: NCT03644511

Last Updated: 2020-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-24

Study Completion Date

2019-09-30

Brief Summary

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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

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Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with HCC

Treated with Nexavar and/or Stivarga as ≥ 2nd-line systemic treatment

Regorafenib (Stivarga, BAY73-4506)

Intervention Type DRUG

Prescribed by physician.

Sorafenib (Nexavar, BAY43-9006)

Intervention Type DRUG

Prescribed by physician.

Interventions

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Regorafenib (Stivarga, BAY73-4506)

Prescribed by physician.

Intervention Type DRUG

Sorafenib (Nexavar, BAY43-9006)

Prescribed by physician.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many Locations

Multiple Locations, , Germany

Site Status

Countries

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Germany

Related Links

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https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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20215

Identifier Type: -

Identifier Source: org_study_id

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