Unique ID issued by UMIN | UMIN000004215 |
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Receipt number | R000005065 |
Scientific Title | Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2016/07/27 15:24:01 |
Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma
Safety and Efficacy Study of Sorafenib in Japanese patients with Advanced Hepatocellular Carcinoma
Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma
Safety and Efficacy Study of Sorafenib in Japanese patients with Advanced Hepatocellular Carcinoma
Japan |
Advanced Hepatcellular Carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the efficacy and safety of Sorafenib for Japanese Child-Pugh A and B patients with advanced hepatocellular carcinoma.
Safety,Efficacy
Exploratory
Phase II
Time to Progression (TTP)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Sorafenib 400mg twice daily
20 | years-old | <= |
Not applicable |
Male and Female
1)Age >= 20 years
2)Patients who have been diagnosed with hepatocellular carcinoma by histologycally or typical diagnostic images
3)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy, transcatheter arterial chemoembolization, radiation therapy)
4)Child-Pugh A or B
5)Performance status (ECOG scale): 0,1 or 2
6)Life expectancy of at least 12 weeks
7)At least 1 target lesion measurable
8)Adequate organ function
1)Second primary malignancy
2)Severe cardiac complication
3)Active infection
4)HIV infection
5)Encephalopacy
6)Gastro-esophazeal varices requiring preventive treatment
7)Uncontrolled massive ascitis
100
1st name | |
Middle name | |
Last name | Osamu Yokosuka |
Chiba University Hospital
Department of Gastroenterology
1-8-1 Inohana, Chuou-ku, Chiba
1st name | |
Middle name | |
Last name | Sadahisa Ogasawara |
Chiba University Hospital
Department of Gastroenterology
ogasawaras@graduate.chiba-u.jp
Chiba University Hospital
None
Self funding
NO
2010 | Year | 10 | Month | 01 | Day |
Published
Completed
2010 | Year | 04 | Month | 19 | Day |
2010 | Year | 05 | Month | 01 | Day |
2010 | Year | 09 | Month | 15 | Day |
2016 | Year | 07 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005065
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