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

NCT03644511 | Terminated

• 1 other identifier: 20215
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

HCC; Liver cancer; Live cell carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapy

  Up to 36 months

• Progression free survival (PFS)

  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

Study Arms (1)

Patients with HCC

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

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

Interventions

Regorafenib (Stivarga, BAY73-4506) DRUG

Prescribed by physician.

Patients with HCC

Sorafenib (Nexavar, BAY43-9006) DRUG

Prescribed by physician.

Patients with HCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with HCC in stage BCLC-B (Barcelona Classification of Liver Cancer) or BCLC-C for whom the decision to treat with Nexavar and/or Stivarga as ≥ 2nd-line has been taken by the investigator and the drugs are prescribed in the customary manner in accordance with the terms of the marketing authorization.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Germany

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

regorafenib; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 23, 2018
• Study Start: January 24, 2019
• Primary Completion: July 18, 2019
• Study Completion: September 30, 2019
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

DE (1)