Unique ID issued by UMIN | UMIN000005703 |
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Receipt number | R000006737 |
Scientific Title | Randomized phase II study of sorafenib and hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma. |
Date of disclosure of the study information | 2011/06/01 |
Last modified on | 2015/07/29 14:28:01 |
Randomized phase II study of sorafenib and hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma.
HCC_Sor_CDDP_rP2
Randomized phase II study of sorafenib and hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma.
HCC_Sor_CDDP_rP2
Japan |
advanced hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
Evaluation of efficacy and safety of combination chemotherapy with sorafenib and hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma.
Safety,Efficacy
Phase II
Overall survival
Time to progression
Advrese events
Sever advrese events
Response rate
Interventional
Parallel
Randomized
Open -no one is blinded
Active
YES
2
Treatment
Medicine |
The combination chemotherapy of sorafenib with transcatheter arterial infusion of cisplatin.
Sorafenib 400mg bid.
6 courses of transcatheter arterial infusion of cisplatin every 4-6 weeks
Sorafenib 400mg bid.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Advanced hepatocellular carcinoma with histological evidence or typical computed tomographic scans, angiographic findings and elevated serum AFP/PIVKA-II level
2) No indication for surgical resection, liver transplantation, local ablation therapy or transarterial chemoembolization
3) No prior chemotherapy
4) Aged 20-79 years old
5) HCCs in the Liver, with or with extrahepatic tumors which not affect patient's prognosis
6) ECOG Performance Status 0-1
7) Adequate organ function
a) Neutrophil>=1500 /mm3
b) Hb>= 8.5 g/dL
c) PLT>= 60000 /mm3
d) T-Bil<= 2.0 mg/dL
e) Albumin>= 2.8 g/dL
f) AST<= within 5 times of normal limit
g) ALT<= within 5 times of normal limit
h) Cre<= 1.2 mg/dl
i) Creatinin cliarance >= 60ml/min
8) Child-Pugh score 5-7 points
9) Adequate indication for hepatic arterial infusion chemotherapy
10) Interval of at least 4 weeks between last treatment and start of present treatment
11) Life expectancy of at least 8 weeks
12) Written informed consent
1) Refractory pleural effusion or ascites
2) Encephalopacy
3) Concurrent disease
a) Serious hypertension
b) Severe heart disease
c) Acute myocardial infarction within 6 months orior to inclusion
d) Active double cancer
e) Severe mental disorder
f) Allergic reaction to iodine contrast material
g) Severe drug allergy
4) Pregnant and lactating females; females of childbearing age unless using effective contraception
5) Inadequate for administration orally
6) Concomitant treatment with drugs inductors of CYP3A4
7) Inadequate physical condition,as diagnosed
by primary physician
105
1st name | |
Middle name | |
Last name | Takuji Okusaka |
National Cancer Center Hospital
Department of Hepatobiliary and Pancreatic Oncology
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
03-3542-2511
tokusaka@ncc.go.jp
1st name | |
Middle name | |
Last name | Satoshi Shimizu |
National Cancer Center Hospital East
Department of Hepatobiliary and Pancreatic Oncology
6-5-1 Kashiwanoha Kashiwa-shi, Chiba-ken, 277-8577 Japan
0471-33-1111
sashimiz@east.ncc.go.jp
National Cancer Center Hospital
Cancer Fundation
Japan
NO
国立がん研究センター中央病院(東京都),国立がん研究センター東病院(千葉県),
栃木県済生会宇都宮病院(栃木県)、神奈川県立がんセンター(神奈川県)、愛知県がんセンター(愛知県)、大阪医療センター(大阪府)、石川県立中央病院(石川県)、国立国際医療研究センター(東京都)、札幌厚生病院(北海道)、手稲渓仁会病院(北海道)、千葉県がんセンター(千葉県)、大阪市立大学医学部附属病院(大阪府)、杏林大学医学部付属病院(東京都)、金沢大学附属病院(石川県)、東京慈恵会医科大学附属病院(東京都)、近畿大学医学部附属病院(大阪府)、岡山大学病院(岡山県)、神戸大学医学部附属病院(兵庫県)、四国がんセンター(愛媛県)、京都府立医科大学附属病院(京都府)、九州がんセンター(福岡県)、がん研有明病院(東京都)、東海大学医学部付属病院(神奈川県)、東京医科大学病院(東京都)、奈良県立医科大学附属病院(奈良県)、獨協医科大学病院(栃木県)、北里大学東病院(神奈川県)、大阪府立成人病センター(大阪府)、栃木県立がんセンター(栃木県)、東京女子医科大学消化器病センター(東京都)、帝京大学医学部附属病院(東京都)、埼玉県立がんセンター(埼玉県)、静岡県立静岡がんセンター(静岡県)、横浜市立大学附属市民総合医療センター(神奈川県)、千葉大学医学部附属病院(千葉県)、福岡大学病院(福岡県)、川崎医科大学附属病院(岡山県)
2011 | Year | 06 | Month | 01 | Day |
Published
Completed
2011 | Year | 04 | Month | 21 | Day |
2011 | Year | 06 | Month | 01 | Day |
2014 | Year | 12 | Month | 19 | Day |
2015 | Year | 01 | Month | 16 | Day |
2015 | Year | 02 | Month | 02 | Day |
2011 | Year | 06 | Month | 01 | Day |
2015 | Year | 07 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006737
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