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).
2 other identifiers
interventional
307
12 countries
100
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2009
Typical duration for phase_2
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 3, 2009
CompletedFirst Posted
Study publicly available on registry
March 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedResults Posted
Study results publicly available
September 24, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedAugust 18, 2017
July 1, 2017
2.3 years
March 3, 2009
August 23, 2012
July 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Progression (TTP) - Independent Radiological Review (Primary Analysis)
TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation.
From randomization of the first participant until 28 months later (cut-off date)
Secondary Outcomes (5)
Overall Survival (OS)
From randomization of the first participant until 28 months later (cut-off date)
Time to Untreatable Progression (TTUP)
From randomization of the first participant until 28 months later (cut-off date)
Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES)
From randomization of the first participant until 28 months later (cut-off date)
Tumor Response - Independent Radiological Review
From randomization of the first participant until 28 months later (cut-off date)
Tumor Response - Investigator Assessment
From randomization of the first participant until 28 months later (cut-off date)
Study Arms (2)
Sorafenib (Nexavar, BAY43-9006) + TACE
EXPERIMENTALSorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
Placebo + TACE
PLACEBO COMPARATORPlacebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
Interventions
800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d. \[twice daily\], 2 tablets). Transarterial Chemoembolization (TACE) using DC Bead
4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead
Eligibility Criteria
You may qualify if:
- 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:
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (107)
Unknown Facility
La Jolla, California, 92037, United States
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Los Angeles, California, 90095-7077, United States
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San Francisco, California, 94115, United States
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Gainesville, Florida, 32610-0316, United States
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Miami, Florida, 33136, United States
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Orlando, Florida, 32804, United States
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Atlanta, Georgia, 30309-1231, United States
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Ann Arbor, Michigan, 48109-0330, United States
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Detroit, Michigan, 48202, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
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St Louis, Missouri, 63104, United States
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New York, New York, 10029, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210-1240, United States
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Portland, Oregon, 97239, United States
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Richmond, Virginia, 23249, United States
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Seattle, Washington, 98101, United States
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Seattle, Washington, 98109-1023, United States
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Camperdown, New South Wales, 2050, Australia
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St Leonards, New South Wales, 2065, Australia
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Greenslopes, Queensland, 4120, Australia
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Clayton, Victoria, 3168, Australia
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Heidelberg, Victoria, 3084, Australia
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Melbourne, Victoria, 3004, Australia
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Nedlands, Western Australia, 6009, Australia
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Innsbruck, 6020, Austria
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Vienna, 1090, Austria
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Bruxelles - Brussel, 1070, Belgium
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Bruxelles - Brussel, 1090, Belgium
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Bruxelles - Brussel, 1200, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Calgary, Alberta, T2N 4N1, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Toronto, Ontario, M5G 2N2, Canada
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Guangzhou, Guangdong, 510060, China
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Guangzhou, Guangdong, 510080, China
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Xi'an, Shannxi, 710032, China
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Beijing, 100021, China
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Beijing, 100142, China
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Shanghai, 200032, China
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Shanghai, 200438, China
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Créteil, 94010, France
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Lille, 59037, France
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Lyon, 69003, France
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Lyon, 69288, France
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Marseille, 13005, France
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Paris, 75020, France
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Paris, 75571, France
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Vandœuvre-lès-Nancy, 54500, France
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Villejuif, 94800, France
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Villejuif, 94805, France
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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Heidelberg, Baden-Wurttemberg, 69120, Germany
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Tübingen, Baden-Wurttemberg, 72076, Germany
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Erlangen, Bavaria, 91054, Germany
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München, Bavaria, 81377, Germany
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Regensburg, Bavaria, 93042, Germany
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Frankfurt am Main, Hesse, 60590, Germany
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Hanover, Lower Saxony, 30625, Germany
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Essen, North Rhine-Westphalia, 45136, Germany
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Essen, North Rhine-Westphalia, 45147, Germany
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Münster, North Rhine-Westphalia, 48149, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Homburg, Saarland, 66421, Germany
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Jena, Thuringia, 07743, Germany
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Berlin, 13353, Germany
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Hamburg, 20246, Germany
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Bari, Apulia, 70021, Italy
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Napoli, Campania, 80131, Italy
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Bologna, Emilia-Romagna, 40138, Italy
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Rome, Lazio, 00133, Italy
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Rome, Lazio, 00185, Italy
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Milan, Lombardy, 20122, Italy
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Milan, Lombardy, 20133, Italy
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Turin, Piedmont, 10126, Italy
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Palermo, Sicily, 90127, Italy
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Pisa, Tuscany, 56124, Italy
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Padua, Veneto, 35128, Italy
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Verona, Veneto, 37134, Italy
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Singapore, 119228, Singapore
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Singapore, 169610, Singapore
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Daegu, 700-721, South Korea
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Gyeonggi-do, 411-706, South Korea
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
Gangnam Severance Hospital, Yonsei University
Seoul, 135-720, South Korea
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Santiago de Compostela, A Coruña, 15706, Spain
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Badalona, Barcelona, 08916, Spain
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Sabadell, Barcelona, 08208, Spain
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Cruces/Barakaldo, Bilbao, 48903, Spain
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Barcelona, Catalonia, 08035, Spain
Fundación Hospital Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
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San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain
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A Coruña, 15006, Spain
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Alicante, 03010, Spain
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Barcelona, 08036, Spain
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Córdoba, 14004, Spain
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Madrid, 28034, Spain
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Madrid, 28046, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
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Valencia, 46014, Spain
Changhua Christian Hospital
Changhua, 500, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11217, Taiwan
Related Publications (1)
Lencioni R, Llovet JM, Han G, Tak WY, Yang J, Guglielmi A, Paik SW, Reig M, Kim DY, Chau GY, Luca A, Del Arbol LR, Leberre MA, Niu W, Nicholson K, Meinhardt G, Bruix J. Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial. J Hepatol. 2016 May;64(5):1090-1098. doi: 10.1016/j.jhep.2016.01.012. Epub 2016 Jan 22.
PMID: 26809111DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2009
First Posted
March 4, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2011
Study Completion
February 1, 2013
Last Updated
August 18, 2017
Results First Posted
September 24, 2012
Record last verified: 2017-07