Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003667

Trial Description

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Title

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).

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study will look at whether our drug (sorafenib) in combination with chemotherapy
delivered directly into your tumor using beads (DC Bead) will slow the progression of the
disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing
the adverse effects that normally occur with chemotherapy.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00003667
  •   2012/05/09
  •   2009/03/03
  •   no
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Secondary IDs

  •   2008-005056-24 
  •   NCT00855218  (ClinicalTrials.gov)
  •   12918  (Bayer)
  •   2008-005056-24 
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Health Condition or Problem studied

  •   Carcinoma, Hepatocellular
  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
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Interventions/Observational Groups

  •   Drug: Sorafenib (Nexavar, BAY43-9006)
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Time to Progression (TTP) - Independent Radiological Review (Primary Analysis); time frame: From randomization of the first subject until 28 months later (cut-off date); 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.

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Secondary Outcome

- Overall Survival (OS); time frame: From randomization of the first subject until 28 months later (cut-off date); Overall Survival (OS) was defined as the time (days) from randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
- Time to Untreatable Progression (TTUP); time frame: From randomization of the first subject until 28 months later (cut-off date); Time to untreatable progression (TTUP) was defined as the time (days) from randomization to untreatable progression. Subjects without untreatable progression at the time of analysis were censored at their last date of tumor evaluation.
- Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES); time frame: From randomization of the first subject until 28 months later (cut-off date); Time to vascular invasion/extrahepatic spread (TTVI/ES) was defined as the time (days) from randomization to vascular invasion/extrahepatic spread. Subjects without vascular invasion/extrahepatic spread at the time of analysis were censored at their last date of tumor evaluation.
- Tumor Response - Independent Radiological Review; time frame: From randomization of the first subject until 28 months later (cut-off date); Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Tumor Response - Investigator Assessment; time frame: From randomization of the first subject until 28 months later (cut-off date); Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   China
  •   France
  •   Germany
  •   Italy
  •   Korea, Republic of
  •   Singapore
  •   Spain
  •   Taiwan, Province of China
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Locations of Recruitment

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Recruitment

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  •   2009/03/31
  •   307
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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:

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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.

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer
    • Bayer Study Director 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2013/02/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   10
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.