Trial Condition(s):
Carcinoma, Hepatocellular
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).
Bayer Identifier:
12918
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jena, Germany, 07743 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erlangen, Germany, 91054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Regensburg, Germany, 93042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Münster, Germany, 48149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98109-1023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60590 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Homburg, Germany, 66421 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ann Arbor, United States, 48109-0330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Jolla, United States, 92037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Detroit, United States, 48202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30309-1231 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Abbott Northwestern Hospital Minneapolis, United States, 55407 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orlando, United States, 32804 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90095-7077 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43210-1240 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gainesville, United States, 32610-0316 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44195 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Francisco, United States, 94115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VILLEJUIF, France, 94805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Marseille, France, 13005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CRETEIL, France, 94010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisa, Italy, 56124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Richmond, United States, 23249 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LYON CEDEX, France, 69288 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VANDOEUVRE-LES-NANCY, France, 54500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75571 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VILLEJUIF, France, 94800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00185 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Verona, Italy, 37134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palermo, Italy, 90127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bari, Italy, 70021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Córdoba, Spain, 14004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site A Coruña, Spain, 15006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Hospital Alcorcón Alcorcón, Spain, 28922 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Central de Asturias Oviedo, Spain, 33006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 2N2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calgary, Canada, T2N 4N1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halifax, Canada, B3H 2Y9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Australia, 3084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greenslopes, Australia, 4120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100142 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200438 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xi'an, China, 710032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 120-752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gyeonggi-do, South Korea, 411-706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Daegu, South Korea, 700-721 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 10002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 169610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cruces/Barakaldo, Spain, 48903 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Laguna, Spain, 38320 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alicante, Spain, 03010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Leonards, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Camperdown, Australia, 2050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nedlands, Australia, 6009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Melbourne, Australia, 3004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clayton, Australia, 3168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site beijing, China, 100021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gangnam Severance Hospital, Yonsei University Seoul, South Korea, 135-720 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 119228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lyon, France, 69003 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Time to progression (TTP) – Independent radiological review (primary analysis)Timeframe: From randomization of the first subject until 28 months later (cut-off date)
Secondary Outcome
- Overall survival (OS)Timeframe: From randomization of the first subject until 28 months later (cut-off date)
- Time to untreatable progression (TTUP)Timeframe: From randomization of the first subject until 28 months later (cut-off date)
- Time to vascular invasion/extrahepatic spread (TTVI/ES)Timeframe: From randomization of the first subject until 28 months later (cut-off date)
- Tumor response - Independent radiological reviewTimeframe: From randomization of the first subject until 28 months later (cut-off date)
- Tumor response – Investigator assessmentTimeframe: From randomization of the first subject until 28 months later (cut-off date)
Additional Information
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