check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

16628

ClinicalTrials.gov Identifier:

NCT01908322

EudraCT Number:

Not Available

EU CT Number:

Not Available
Investigating patient characteristics of intermediate stage hepatocellular carcinoma patients treated with Nexavar and their distribution to different treatment groups as well as determining effectiveness and safety

Trial purpose

The study aims to investigate patient characteristics of intermediate stage hepatocellular carcinoma patients treated with Nexavar and their distribution to different treatment groups as well as determining efficacy and safety parameters.

Key Participants Requirements

Sex

Both

Age

0 - N/A
  • - Patients with a diagnosis of unresectable intermediate stage hepatocellular carcinoma (BCLC-B) for whom the decision has been taken by the investigator to prescribe Nexavar (the BCLC intermediate stage (BCLC-B) consists of Child-Pugh A and B patients with large/multifocal HCC who do not have cancer related symptoms, macrovascular invasion or extrahepatic spread).

  • - Prior targeted therapy for hepatocellular carcinoma.

Trial summary

Enrollment Goal
19
Trial Dates
August 2013 - September 2015
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

Primary Outcome

  • Distribution of intermediate stage hepatocellular carcinoma (HCC) patients treated with Nexavar to different treatment groups will be evaluated by the relative frequency of patients in each treatment group.
    date_rangeTime Frame:
    up to 54 months
    enhanced_encryption
    Safety Issue:
    No
  • Characteristics of patients with intermediate stage HCC (BCLC-B) treated with Nexavar will be determined by evaluating demographic data, medical history, previous treatment of HCC, specific concomitant conditions (amongst others).
    date_rangeTime Frame:
    up to 54 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason.
    date_rangeTime Frame:
    up to 54 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.
    date_rangeTime Frame:
    up to 54 months
    enhanced_encryption
    Safety Issue:
    No
  • Progression free survival is measured as the time interval from the start of Nexavar treatment to diagnosed (radiological or clinical) progression or death, whichever comes first.
    date_rangeTime Frame:
    up to 54 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression or permanent discontinuation due to toxicity.
    date_rangeTime Frame:
    up to 54 months
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Nexavar treatment is measured as the time interval from start of Nexavar therapy to the date of permanent discontinuation of Nexavar therapy (regardless of the reason for discontinuation).
    date_rangeTime Frame:
    up to 54 months
    enhanced_encryption
    Safety Issue:
    No
  • Tumor status at different visits will be evaluated according to radiological or clinical evaluation. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.
    date_rangeTime Frame:
    up to 54 months
    enhanced_encryption
    Safety Issue:
    No
  • Further possible prognostic factors will be evaluated.
    date_rangeTime Frame:
    up to 54 months
    enhanced_encryption
    Safety Issue:
    No
  • Safety variables will be summarized using descriptive statistics based on adverse events collection.
    date_rangeTime Frame:
    up to 54 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

SORINT - SORafenib for treatment of patients with INTermediate stage hepatocellular carcinoma
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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