Unique ID issued by UMIN | UMIN000008581 |
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Receipt number | R000010081 |
Scientific Title | Comparison between coagulations of RFA with sorafenib and standard RFA in patients with HCC. |
Date of disclosure of the study information | 2012/07/31 |
Last modified on | 2014/08/04 15:58:39 |
Comparison between coagulations of RFA with sorafenib and standard RFA in patients with HCC.
Comparison between coagulations of RFA with sorafenib and standard RFA in patients with HCC.
Comparison between coagulations of RFA with sorafenib and standard RFA in patients with HCC.
Comparison between coagulations of RFA with sorafenib and standard RFA in patients with HCC.
Japan |
Hepatocellular carcinoma (HCC)
Hepato-biliary-pancreatic medicine |
Malignancy
NO
We compare the coagulation diameters for RFA with Sorafenib and standard RFA on CT scans obtained 1 week after treatment.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
coagulation effect
(1)bebore,1 week after,4 weeks after,change of tumor marker
(2)blood flow changes before and after Sorafenib
(3)changes of liver function
(4)histological changes before and after Sorafenib
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Before RFA, Sorafenib 800mg /day x 7 days po
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1)HCC patients admitted at this hospital and Child-Pugh Score<=9
2)Performance status:0-2
3)HCC diagnoed by image diagnosis or histology
4)patients with <=3 lesions of small and <=3 cm diameter
5)patients at the age of>=20 and <=80
6)patients who understand this study and sign an informed consent form at the time of enrollment.
1)T-Bil >=3.0mg/dl,PT <=50%
2)patients during pregnacy, lactation period, or who have a plan to be pregnant
3)patients with massive fluid
4)patient the doctor judged as a non-indication
5)patients with tumor thrombus in the main trunk of portal vein or bile duct
6)severe portal hypertention with treatment-resistant gastric or esophageal varices
7)treatment-resistant ascites
8)bleeding tendency(Plt <=50000/mm3)
9)patients with their prognosis <3 months
10)patient the doctor judged as a non-indication from the medical or mental status
170
1st name | |
Middle name | |
Last name | Kazushi Numata |
Yokohama City University Medical Center
Gastroenterlogical Center
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
045-261-5656
1st name | |
Middle name | |
Last name | Hiroyuki Fukuda |
Yokohama City University Medical Center
Gastroenterlogical Center
Yokohama City University Medical Center
fukuhiro@yokohama-cu.ac.jp
Yokohama City University Medical Center
None
Self funding
Japan
NO
2012 | Year | 07 | Month | 31 | Day |
Published
http://dx.doi.org/10.1148/radiol.14131640
Sorafenib-RFA may be superior to standard RFA alone in the treatment of HCC tumors smaller than 3 cm in diameter.
Main results already published
2011 | Year | 10 | Month | 01 | Day |
2011 | Year | 10 | Month | 01 | Day |
2012 | Year | 07 | Month | 31 | Day |
2014 | Year | 08 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010081
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