check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

12918

ClinicalTrials.gov Identifier:

NCT00855218

EudraCT Number:

2008-005056-24

EU CT Number:

Not Available
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).

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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.

Trial summary

Enrollment Goal
307
Trial Dates
March 2009 - February 2013
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Freiburg, 79106, Germany
Terminated
Tübingen, 72076, Germany
Completed
Heidelberg, 69120, Germany
Terminated
Hannover, 30625, Germany
Terminated
Jena, 07743, Germany
Completed
Erlangen, 91054, Germany
Completed
Regensburg, 93042, Germany
Completed
Münster, 48149, Germany
Completed
Essen, 45136, Germany
Completed
New York, 10029, United States
Terminated
Seattle, 98109-1023, United States
Completed
St. Louis, 63104, United States
Completed
Portland, 97239, United States
Completed
Hamburg, 20246, Germany
Terminated
Berlin, 13353, Germany
Completed
Mainz, 55131, Germany
Completed
Essen, 45147, Germany
Completed
München, 81377, Germany
Completed
Frankfurt, 60590, Germany
Completed
Homburg, 66421, Germany
Terminated
Ann Arbor, 48109-0330, United States
Terminated
La Jolla, 92037, United States
Completed
Miami, 33136, United States
Terminated
Detroit, 48202, United States
Completed
Atlanta, 30309-1231, United States
Completed
Abbott Northwestern HospitalMinneapolis, 55407, United States
Completed
Orlando, 32804, United States
Terminated
Los Angeles, 90095-7077, United States
Completed
Columbus, 43210-1240, United States
Completed
Gainesville, 32610-0316, United States
Terminated
Cleveland, 44195, United States
Completed
Seattle, 98101, United States
Completed
San Francisco, 94115, United States
Completed
VILLEJUIF, 94805, France
Completed
PARIS, 75020, France
Completed
Marseille, 13005, France
Completed
CRETEIL, 94010, France
Completed
Pisa, 56124, Italy
Completed
Bologna, 40138, Italy
Terminated
Roma, 00133, Italy
Completed
Milano, 20133, Italy
Completed
Torino, 10126, Italy
Completed
Richmond, 23249, United States
Completed
LYON CEDEX, 69288, France
Completed
VANDOEUVRE-LES-NANCY, 54500, France
Completed
LILLE, 59037, France
Completed
PARIS, 75571, France
Completed
VILLEJUIF, 94800, France
Completed
Milano, 20122, Italy
Completed
Padova, 35128, Italy
Terminated
Napoli, 80131, Italy
Completed
Roma, 00185, Italy
Completed
Verona, 37134, Italy
Completed
Palermo, 90127, Italy
Completed
Bari, 70021, Italy
Completed
Badalona, 08916, Spain
Completed
Barcelona, 08035, Spain
Completed
Córdoba, 14004, Spain
Terminated
A Coruña, 15006, Spain
Completed
Fundación Hospital AlcorcónAlcorcón, 28922, Spain
Completed
Hospital Central de AsturiasOviedo, 33006, Spain
Completed
Sabadell, 08208, Spain
Completed
Madrid, 28034, Spain
Completed
Toronto, M5G 2N2, Canada
Completed
Calgary, T2N 4N1, Canada
Completed
Halifax, B3H 2Y9, Canada
Completed
LIEGE, 4000, Belgium
Completed
LEUVEN, 3000, Belgium
Completed
Heidelberg, 3084, Australia
Completed
Greenslopes, 4120, Australia
Completed
Wien, 1090, Austria
Completed
Guangzhou, 510060, China
Completed
Beijing, 100142, China
Completed
Shanghai, 200438, China
Completed
Shanghai, 200032, China
Terminated
Guangzhou, 510080, China
Completed
Xi'an, 710032, China
Completed
Seoul, 120-752, Korea, Republic Of
Completed
Seoul, 110-744, Korea, Republic Of
Terminated
Gyeonggi-do, 411-706, Korea, Republic Of
Completed
Daegu, 700-721, Korea, Republic Of
Completed
Changhua Christian HospitalChanghua, 500, Taiwan
Completed
Taipei, 10002, Taiwan
Completed
Taipei, 11217, Taiwan
Completed
Singapore, 169610, Singapore
Completed
Barcelona, 08036, Spain
Completed
Cruces/Barakaldo, 48903, Spain
Completed
La Laguna, 38320, Spain
Completed
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Completed
Madrid, 28046, Spain
Completed
Alicante, 03010, Spain
Completed
Valencia, 46014, Spain
Completed
Santiago de Compostela, 15706, Spain
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Terminated
BRUXELLES - BRUSSEL, 1090, Belgium
Terminated
St Leonards, 2065, Australia
Completed
Camperdown, 2050, Australia
Completed
Nedlands, 6009, Australia
Completed
Melbourne, 3004, Australia
Completed
Clayton, 3168, Australia
Completed
Innsbruck, 6020, Austria
Completed
beijing, 100021, China
Terminated
Gyeonggi-do, 411-706, Korea, Republic Of
Completed
Seoul, 135-710, Korea, Republic Of
Terminated
Gangnam Severance Hospital, Yonsei UniversitySeoul, 135-720, Korea, Republic Of
Terminated
Singapore, 119228, Singapore
Completed
Lyon, 69003, France

Primary Outcome

  • Time to progression (TTP) – Independent radiological review (primary analysis)
    date_rangeTime Frame:
    From randomization of the first subject until 28 months later (cut-off date)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall survival (OS)
    date_rangeTime Frame:
    From randomization of the first subject until 28 months later (cut-off date)
    enhanced_encryption
    Safety Issue:
    No
  • Time to untreatable progression (TTUP)
    date_rangeTime Frame:
    From randomization of the first subject until 28 months later (cut-off date)
    enhanced_encryption
    Safety Issue:
    No
  • Time to vascular invasion/extrahepatic spread (TTVI/ES)
    date_rangeTime Frame:
    From randomization of the first subject until 28 months later (cut-off date)
    enhanced_encryption
    Safety Issue:
    No
  • Tumor response - Independent radiological review
    date_rangeTime Frame:
    From randomization of the first subject until 28 months later (cut-off date)
    enhanced_encryption
    Safety Issue:
    No
  • Tumor response – Investigator assessment
    date_rangeTime Frame:
    From randomization of the first subject until 28 months later (cut-off date)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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).
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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