stop_circleTerminated/Withdrawn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
  • - 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.
  • - 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
3
Trial Dates
January 2019 - September 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Many LocationsMany 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
    date_rangeTime Frame:
    Up to 24 months

Secondary Outcome

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

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