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Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Hepatocellular

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Trial Information

Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)


Inclusion Criteria:



- Male or female

- Aged of 18 and over

- Advanced hepatocellular carcinoma

Exclusion Criteria:

- History of prior systemic chemotherapy

- Failure in vital organ

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to Progression (TTP)

Outcome Description:

Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.

Outcome Time Frame:

From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

11721

NCT ID:

NCT00494299

Start Date:

April 2006

Completion Date:

November 2010

Related Keywords:

  • Carcinoma, Hepatocellular
  • HCC
  • Cancer
  • Liver Cancer
  • TACE
  • Carcinoma
  • Carcinoma, Hepatocellular

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