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A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Hepatocellular

Thank you

Trial Information

A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).


Safety issues will be reported in Adverse Event section. In addition to the secondary
outcome measures, Biomarkers and Patient Report Outcome will also be analyzed as other
variables.


Inclusion Criteria:



- Unresectable, multinodular asymptomatic tumor without vascular invasion or
extrahepatic spread

- Confirmed Diagnosis of HCC:

- Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver
Diseases (AASLD) criteria

- HCC can be defined in cirrhotic subjects by one imaging technique (Computed
tomography [CT] scan, Magnetic resonance imaging [MRI], or second generation contrast
ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial
phase and washout in venous or late phases or two imaging techniques showing this
radiological behavior for nodules of 1-2 cm in diameter.

- Cytohistological confirmation is required for subjects who do not fulfill these
eligibility criteria.

- Non-cirrhotic subjects:

For subjects without cirrhosis, histological or cytological confirmation is mandatory

- Documentation of original biopsy for diagnosis is acceptable

- Child Pugh class A without ascites

- Adequate bone marrow, liver and renal function as assessed by central lab by means of
the following laboratory requirements from samples within 7 days prior to
randomization:

Exclusion Criteria:

- Patients on a liver transplantation list or with advanced liver disease as defined
below:

- Child Pugh B and C

- Active gastrointestinal bleeding

- Encephalopathy

- Ascites

- Lesions having previously been treated with local therapy such as resection of HCC,
radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation
can not be selected as the target lesions.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to Progression (TTP) - Independent Radiological Review (Primary Analysis)

Outcome Description:

TTP is defined as the time (days) from randomization to radiological confirmed disease progression. 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 28 months later (cut-off date)

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Austria: Ethikkommission

Study ID:

12918

NCT ID:

NCT00855218

Start Date:

March 2009

Completion Date:

February 2013

Related Keywords:

  • Carcinoma, Hepatocellular
  • Sorafenib
  • TACE
  • DC bead
  • Combination
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Alexandria, Minnesota  56308
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Eugene, Oregon