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

Bayer

Status: Terminated

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Regorafenib (Stivarga, BAY73-4506)

Study type: Observational

Funder types: Industry

Identifiers

NCT03644511

20215

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3 participants in 1 patient group

Patients with HCC

Description:

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

Treatment:

Drug: Regorafenib (Stivarga, BAY73-4506)

Drug: Sorafenib (Nexavar, BAY43-9006)