Terminated/Withdrawn

Hepatocellular Carcinoma

Bayer Identifier:

20215

ClinicalTrials.gov Identifier:

NCT03644511

EudraCT Number:

Not Available

EU CT Number:

Not Available

Use of Sorafenib and/or Regorafenib in liver cancer (hepatocellular carcinoma) subsequent to another systemic first-line treatment

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A

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 summary

Enrollment Goal

Trial Dates

January 2019 - September 2019

Phase

Phase 4

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Terminated	Many Locations	Many Locations, Germany

Primary Outcome

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
Time Frame:
Up to 24 months

Secondary Outcome

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

Trial design

Use of Sorafenib and/or Regorafenib in hepatocellular carcinoma (HCC) subsequent to another systemic first-line treatment

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

Click here to find results for studies related to Bayer products