Trial Condition(s):

Carcinoma, Hepatocellular

Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM) (STORM)

Bayer Identifier:

12414

ClinicalTrials.gov Identifier:

NCT00692770

EudraCT Number:

2008-001087-36

Study Completed

Trial Purpose

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).

Inclusion Criteria
- Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period. 
- At least 3 weeks (21 days) but no more than 7 weeks (49 days), from resection or last local ablation course, to CT/MRI scan date
- Male or female subjects >/= 18 years of age 
- Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.
- For subjects undergoing surgical resection pathology proven complete removal of tumor.
- Intermediate or High Risk of recurrence as assessed by tumor characteristics. 
- Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites. 
- ECOG Performance Status of 0.
- Adequate bone marrow, liver and renal function
Exclusion Criteria
- Recurrent HCC
- Child-Pugh score 7 points with presence of ascites. 
- Low risk of recurrence after curative treatment  
- History of cardiovascular disease 
- History of HIV infection 
- Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0) 
- Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
- Subjects with evidence or history of bleeding diathesis
- Subjects undergoing renal dialysis
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry as defined by the signing of informed consent..
- Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
- Encephalopathy
- History of GI bleeding within 30 days of randomization. 
- Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence. 
- Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.
- Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC.
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent.
- Liver transplantation, this includes patients on a transplant list with the intention to transplant

Trial Summary

Enrollment Goal
1114
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

München, Germany, 81675

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 12200

Status
Completed
 
Locations

Investigative Site

Aachen, Germany, 52074

Status
Completed
 
Locations

Investigative Site

Regensburg, Germany, 93042

Status
Completed
 
Locations

Investigative Site

Göttingen, Germany, 37075

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, NW3 2QG

Status
Completed
 
Locations

Investigative Site

Birmingham, United Kingdom, B15 2TT

Status
Completed
 
Locations

Investigative Site

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
Locations

Investigative Site

Leeds, United Kingdom, LS9 7TF

Status
Completed
 
Locations

Investigative Site

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
Locations

Investigative Site

New York, United States, 10029

Status
Completed
 
Locations

Investigative Site

Miami, United States, 33136

Status
Completed
 
Locations

Investigative Site

Indianapolis, United States, 46202

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 20246

Status
Completed
 
Locations

Investigative Site

Halle/Saale, Germany, 06120

Status
Completed
 
Locations

Investigative Site

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

Investigative Site

Mainz, Germany, 55131

Status
Completed
 
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Investigative Site

Essen, Germany, 45147

Status
Completed
 
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Investigative Site

Hannover, Germany, 30625

Status
Completed
 
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Magdeburg, Germany, 39120

Status
Completed
 
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Investigative Site

Köln, Germany, 50937

Status
Completed
 
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Investigative Site

Homburg/Saar, Germany, 66421

Status
Completed
 
Locations

Investigative Site

München, Germany, 81377

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, SE5 9RS

Status
Completed
 
Locations

Investigative Site

Manchester, United Kingdom, M20 4BX

Status
Completed
 
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Washington, United States, 20007

Status
Completed
 
Locations

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Los Angeles, United States, 90033

Status
Completed
 
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Minneapolis, United States, 55455

Status
Completed
 
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Phoenix, United States, 85054

Status
Completed
 
Locations

Providence Portland Medical Center

Portland, United States, 97213

Status
Terminated
 
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Investigative Site

Richmond, United States, 23249

Status
Completed
 
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Investigative Site

Birmingham, United States, 35294-3300

Status
Completed
 
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Investigative Site

BONDY, France, 93143

Status
Completed
 
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Investigative Site

VANDOEUVRE-LES-NANCY, France, 54500

Status
Completed
 
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Investigative Site

PARIS, France, 75020

Status
Completed
 
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Investigative Site

PARIS, France, 75571

Status
Completed
 
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Investigative Site

MARSEILLE, France, 13005

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98109

Status
Completed
 
Locations

Investigative Site

Ann Arbor, United States, 48109

Status
Completed
 
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Investigative Site

Pittsburgh, United States, 15213

Status
Completed
 
Locations

Investigative Site

Portland, United States, 97239

Status
Completed
 
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Boston, United States, 02114

Status
Completed
 
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Los Angeles, United States, 90095-7077

Status
Completed
 
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Houston, United States, 77030

Status
Completed
 
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Columbus, United States, 43210

Status
Completed
 
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Burlington, United States, 01805

Status
Completed
 
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Investigative Site

Cleveland, United States, 44195

Status
Completed
 
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New Orleans, United States, 70112

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Completed
 
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Seattle, United States, 98101

Status
Completed
 
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Investigative Site

San Francisco, United States, 94115

Status
Completed
 
Locations

Investigative Site

ANGERS cedex 09, France, 49933

Status
Completed
 
Locations

Investigative Site

CRETEIL, France, 94010

Status
Completed
 
Locations

Investigative Site

RENNES, France, 35000

Status
Completed
 
Locations

Investigative Site

VILLEJUIF, France, 94800

Status
Completed
 
Locations

Investigative Site

Yokohama-shi, Japan, 232-0024

Status
Completed
 
Locations

Investigative Site

Shibuya-ku, Japan, 150-8935

Status
Completed
 
Locations

Investigative Site

Osakasayama-shi, Japan, 589-8511

Status
Completed
 
Locations

Investigative Site

Kumamoto, Japan, 860-8556

Status
Completed
 
Locations

Investigative Site

Kyoto, Japan, 606-8507

Status
Completed
 
Locations

Investigative Site

Itabashi-ku, Japan, 173-8610

Status
Completed
 
Locations

Investigative Site

Suita, Japan, 565-0871

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 537-8511

Status
Completed
 
Locations

Investigative Site

Minato-ku, Japan, 105-8470

Status
Completed
 
Locations

Investigative Site

Bologna, Italy, 40138

Status
Completed
 
Locations

Investigative Site

Atlanta, United States, 30322

Status
Completed
 
Locations

Investigative Site

Louisville, United States, 40202

Status
Completed
 
Locations

Investigative Site

Minneapolis, United States, 55407

Status
Completed
 
Locations

Investigative Site

Baltimore, United States, 21287

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44106

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02215

Status
Completed
 
Locations

Investigative Site

BORDEAUX, France, 33000

Status
Completed
 
Locations

Investigative Site

LILLE, France, 59037

Status
Completed
 
Locations

Investigative Site

TOULOUSE, France, 31059

Status
Completed
 
Locations

Investigative Site

LYON, France, 69004

Status
Completed
 
Locations

Investigative Site

NICE, France, 06202

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Investigative Site

Chuo-ku, Japan, 104-0045

Status
Completed
 
Locations

Investigative Site

Kashiwa-shi, Japan, 277-8577

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20121

Status
Completed
 
Locations

Investigative Site

Cagliari, Italy, 09134

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20133

Status
Completed
 
Locations

Investigative Site

Padova, Italy, 35128

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Córdoba, Spain, 14004

Status
Completed
 
Locations

Investigative Site

Valladolid, Spain, 47012

Status
Completed
 
Locations

Investigative Site

Oviedo, Spain, 33011

Status
Completed
 
Locations

Investigative Site

Sabadell, Spain, 08208

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M5G 2M9

Status
Completed
 
Locations

Investigative Site

Calgary, Canada, T2N 4N1

Status
Completed
 
Locations

Investigative Site

Ottawa, Canada, K1H 8L6

Status
Completed
 
Locations

Investigative Site

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Investigative Site

Vancouver, Canada, V5Z 4E6

Status
Completed
 
Locations

Investigative Site

Okayama, Japan, 700-8558

Status
Completed
 
Locations

Investigative Site

Kanazawa, Japan, 920-8641

Status
Completed
 
Locations

Investigative Site

Tokushima, Japan, 770-8503

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 162-8666

Status
Completed
 
Locations

Investigative Site

Napoli, Italy, 80123

Status
Completed
 
Locations

Investigative Site

Palermo, Italy, 90127

Status
Completed
 
Locations

Investigative Site

Benevento, Italy, 82100

Status
Completed
 
Locations

Investigative Site

Roma, Italy, 00168

Status
Completed
 
Locations

Investigative Site

Catania, Italy, 95122

Status
Completed
 
Locations

Investigative Site

Torino, Italy, 10126

Status
Completed
 
Locations

Investigative Site

Bari, Italy, 70124

Status
Completed
 
Locations

Investigative Site

Modena, Italy, 41124

Status
Completed
 
Locations

Investigative Site

Napoli, Italy, 80131

Status
Completed
 
Locations

Investigative Site

Cruces/Barakaldo, Spain, 48903

Status
Completed
 
Locations

Investigative Site

Majadahonda, Spain, 28222

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

México, D.F., Mexico, 14080

Status
Completed
 
Locations

Investigative Site

Stockholm, Sweden, 141 86

Status
Completed
 
Locations

Investigative Site

Heidelberg, Australia, 3084

Status
Completed
 
Locations

Investigative Site

Randwick, Australia, 2031

Status
Completed
 
Locations

Investigative Site

Melbourne, Australia, 3004

Status
Completed
 
Locations

Investigative Site

Varna, Bulgaria, 2010

Status
Completed
 
Locations

Investigative Site

Plovdiv, Bulgaria, 4002

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28040

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28007

Status
Completed
 
Locations

Investigative Site

Badajoz, Spain, 06080

Status
Completed
 
Locations

Investigative Site

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Investigative Site

GENT, Belgium, 9000

Status
Completed
 
Locations

Investigative Site

Monterrey, Mexico, 64710

Status
Completed
 
Locations

Investigative Site

México, D.F., Mexico, 14050

Status
Completed
 
Locations

Investigative Site

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Investigative Site

Camperdown, Australia, 2050

Status
Completed
 
Locations

Investigative Site

Brisbane, Australia, 4120

Status
Completed
 
Locations

Investigative Site

Linz, Austria, 4020

Status
Completed
 
Locations

Investigative Site

Reñaca, Chile

Status
Completed
 
Locations

Investigative Site

Porto Alegre, Brazil, 90610-000

Status
Completed
 
Locations

Investigative Site

Porto Alegre, Brazil, 90035-903

Status
Completed
 
Locations

Investigative Site

Sao Paulo, Brazil, 01246-903

Status
Completed
 
Locations

Investigative Site

Obninsk, Russia, 249036

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 115478

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510060

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510080

Status
Completed
 
Locations

Investigative Site

Chengdu, China, 610041

Status
Completed
 
Locations

Investigative Site

Nanjing, China, 210002

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200438

Status
Completed
 
Locations

Investigative Site

Coimbra, Portugal, 3000-075

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1181ACH

Status
Completed
 
Locations

Investigative Site

Pilar, Argentina, B1629ODT

Status
Completed
 
Locations

Investigative Site

Rosario, Argentina, S2002KDS

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Santiago de Chile, Chile, 833-0024

Status
Completed
 
Locations

Investigative Site

Athens / Greece, Greece, 115 27

Status
Completed
 
Locations

Investigative Site

Porto Alegre, Brazil, 90470 340

Status
Completed
 
Locations

Investigative Site

Wuhan, China, 430022

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510515

Status
Completed
 
Locations

Investigative Site

Chongqing, China, 400038

Status
Completed
 
Locations

Investigative Site

Xi'an, China, 710068

Status
Completed
 
Locations

Investigative Site

Changsha, China, 410013

Status
Completed
 
Locations

Investigative Site

Dalian, China, 116027

Status
Completed
 
Locations

Investigative Site

Beijng, China, 100142

Status
Completed
 
Locations

Investigative Site

Changsha, China, 410008

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 120-752

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Investigative Site

Goyang-si, South Korea, 411-706

Status
Completed
 
Locations

Investigative Site

São Paulo, Brazil, 01323-001

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 119991

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 197758

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100021

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100142

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100071

Status
Completed
 
Locations

Investigative Site

Xi'an, China, 710061

Status
Completed
 
Locations

Investigative Site

Tianjin, China, 300060

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100853

Status
Completed
 
Locations

Investigative Site

Xi'an, China, 710038

Status
Completed
 
Locations

Investigative Site

Nanning, China, 530021

Status
Completed
 
Locations

Investigative Site

Busan, South Korea, 49241

Status
Completed
 
Locations

Investigative Site

Jeollabuk-do, South Korea, 561-712

Status
Completed
 
Locations

Investigative Site

Bern, Switzerland, 3010

Status
Completed
 
Locations

Investigative Site

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Investigative Site

Kaohsiung City, Taiwan, China, 807

Status
Completed
 
Locations

Investigative Site

Auckland, New Zealand, 1023

Status
Completed
 
Locations

Investigative Site

Cluj-Napoca, Romania, 400015

Status
Completed
 
Locations

Investigative Site

Bucharest, Romania, 022326

Status
Completed
 
Locations

Investigative Site

Hefei, China, 230022

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200001

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 05505

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Investigative Site

Goyang-si, South Korea, 410-769

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 135-720

Status
Completed
 
Locations

Investigative Site

Daegu, South Korea, 700721

Status
Completed
 
Locations

Investigative Site

Changhua, Taiwan, China, 500-06

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 100

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 112

Status
Completed
 
Locations

Investigative Site

Kaohsung, Taiwan, China, 833

Status
Completed
 
Locations

Investigative Site

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 169608

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 119228

Status
Completed
 
Locations

Investigative Site

Iasi, Romania, 700106

Status
Completed
 
Locations

Investigative Site

Chengdu, China, 610072

Status
Completed
 
Locations

Investigative Site

Taoyuan, Taiwan, China, 333

Status
Completed
 
Locations

Investigative Site

Many locations, Taiwan, China, 704

Status
Completed
 
Locations

Investigative Site

Shatin, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

Kwun Tong, Hong Kong, China

Status
Completed
 

Trial Design