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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site München, Germany, 81675 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 12200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aachen, Germany, 52074 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Regensburg, Germany, 93042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göttingen, Germany, 37075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, NW3 2QG | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United Kingdom, B15 2TT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Southampton, United Kingdom, SO16 6YD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leeds, United Kingdom, LS9 7TF | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newcastle Upon Tyne, United Kingdom, NE7 7DN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33136 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Indianapolis, United States, 46202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20246 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halle/Saale, Germany, 06120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Düsseldorf, Germany, 40225 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45147 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Magdeburg, Germany, 39120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50937 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Homburg/Saar, Germany, 66421 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SE5 9RS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manchester, United Kingdom, M20 4BX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Washington, United States, 20007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90033 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Minneapolis, United States, 55455 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Phoenix, United States, 85054 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Providence Portland Medical Center Portland, United States, 97213 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Richmond, United States, 23249 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United States, 35294-3300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BONDY, France, 93143 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VANDOEUVRE-LES-NANCY, France, 54500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75571 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13005 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ann Arbor, United States, 48109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90095-7077 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43210 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Burlington, United States, 01805 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44195 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Orleans, United States, 70112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Francisco, United States, 94115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ANGERS cedex 09, France, 49933 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CRETEIL, France, 94010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site RENNES, France, 35000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VILLEJUIF, France, 94800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama-shi, Japan, 232-0024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shibuya-ku, Japan, 150-8935 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osakasayama-shi, Japan, 589-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kumamoto, Japan, 860-8556 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kyoto, Japan, 606-8507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Itabashi-ku, Japan, 173-8610 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suita, Japan, 565-0871 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8655 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 537-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Minato-ku, Japan, 105-8470 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30322 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Louisville, United States, 40202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Minneapolis, United States, 55407 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baltimore, United States, 21287 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02215 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BORDEAUX, France, 33000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE, France, 59037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE, France, 31059 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LYON, France, 69004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NICE, France, 06202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 812-8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chuo-ku, Japan, 104-0045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kashiwa-shi, Japan, 277-8577 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cagliari, Italy, 09134 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20133 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Córdoba, Spain, 14004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valladolid, Spain, 47012 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oviedo, Spain, 33011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sabadell, Spain, 08208 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 2M9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calgary, Canada, T2N 4N1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1H 8L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Edmonton, Canada, T6G 1Z2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vancouver, Canada, V5Z 4E6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Okayama, Japan, 700-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kanazawa, Japan, 920-8641 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tokushima, Japan, 770-8503 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 162-8666 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palermo, Italy, 90127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Benevento, Italy, 82100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00168 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Catania, Italy, 95122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bari, Italy, 70124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Modena, Italy, 41124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cruces/Barakaldo, Spain, 48903 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Majadahonda, Spain, 28222 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site México, D.F., Mexico, 14080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 141 86 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Australia, 3084 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Randwick, Australia, 2031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Melbourne, Australia, 3004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varna, Bulgaria, 2010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Plovdiv, Bulgaria, 4002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Badajoz, Spain, 06080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEGE, Belgium, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monterrey, Mexico, 64710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site México, D.F., Mexico, 14050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 413 45 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Camperdown, Australia, 2050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brisbane, Australia, 4120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reñaca, Chile | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto Alegre, Brazil, 90610-000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto Alegre, Brazil, 90035-903 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 01246-903 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Obninsk, Russia, 249036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 115478 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chengdu, China, 610041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nanjing, China, 210002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200438 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coimbra, Portugal, 3000-075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1181ACH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pilar, Argentina, B1629ODT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rosario, Argentina, S2002KDS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Chile, Chile, 833-0024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens / Greece, Greece, 115 27 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto Alegre, Brazil, 90470 340 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wuhan, China, 430022 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510515 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chongqing, China, 400038 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xi'an, China, 710068 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Changsha, China, 410013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dalian, China, 116027 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijng, China, 100142 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Changsha, China, 410008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 120-752 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 110-744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Goyang-si, South Korea, 411-706 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site São Paulo, Brazil, 01323-001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 119991 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 197758 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100142 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100071 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xi'an, China, 710061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tianjin, China, 300060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100853 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Xi'an, China, 710038 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nanning, China, 530021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Busan, South Korea, 49241 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jeollabuk-do, South Korea, 561-712 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bern, Switzerland, 3010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zürich, Switzerland, 8091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaohsiung City, Taiwan, China, 807 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Auckland, New Zealand, 1023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cluj-Napoca, Romania, 400015 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bucharest, Romania, 022326 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hefei, China, 230022 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 05505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 135-710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Goyang-si, South Korea, 410-769 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 135-720 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Daegu, South Korea, 700721 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Changhua, Taiwan, China, 500-06 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaohsung, Taiwan, China, 833 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hong Kong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 169608 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 119228 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iasi, Romania, 700106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chengdu, China, 610072 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taoyuan, Taiwan, China, 333 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Taiwan, China, 704 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shatin, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kwun Tong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Phase III randomized, double-blind, placebo-controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Recurrence Free Survival (RFS) by Independent AssessmentDisease recurrence of HCC (intra or extra hepatic) was defined as the appearance of a new intrahepatic lesions fulfilling the American Association for the Study of Liver Diseases (AASLD) criteria of diagnosis of HCC or a new extra-hepatic lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. In addition to investigator assessment, all images were reviewed by an independent panel of radiologists. The calculation of the RFS was based on the independent evaluation of the scans. RFS was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment or death due to any cause whichever occurred first. For subjects who had not recurred or died at the time of analysis, RFS was censored at their last date of evaluable scan before drop-out for any other reason than recurrence or death.Timeframe: From randomization up to 4 years or until disease recurrence whichever came first
Secondary Outcome
- Time to Recurrence (TTR) by Independent AssessmentTTR was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment. For subjects who had not recurred at the time of analysis, TTR was censored at their last date of evaluable scan before withdrawal for any other reason than recurrence. "NA" in the reported data indicates values could not be estimated due to censored data.Timeframe: From randomization up to 4 years or until disease recurrence whichever came first
- Overall Survival (OS)OS was defined as the time from randomization to date of death due to any cause. OS for subjects alive at the time of analysis was censored at their last date of contact. 'NA' in the reported data indicates values could not be estimated due to censored data.Timeframe: From randomization of the first subject until 4 years later.
Additional Information
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