Unique ID issued by UMIN | UMIN000020810 |
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Receipt number | R000024024 |
Scientific Title | Phase II study of segmental transcatheter arterial chemoembolization using iodinated oil mixed with cisplatin powder for unresectable hepatocellular carcinoma |
Date of disclosure of the study information | 2016/01/31 |
Last modified on | 2016/02/03 16:51:06 |
Phase II study of segmental transcatheter arterial chemoembolization using iodinated oil mixed with cisplatin powder for unresectable hepatocellular carcinoma
Lip-TACE for HCC
Phase II study of segmental transcatheter arterial chemoembolization using iodinated oil mixed with cisplatin powder for unresectable hepatocellular carcinoma
Lip-TACE for HCC
Japan |
hepatocellular carcinoma
Hepato-biliary-pancreatic medicine | Radiology |
Malignancy
NO
To assess the safety and efficacy of subsegmental or segmental transcatheter arterial chemoembolization using a suspension of cisplatin powder mixed with iodized oil for unresectable hepatocellular carcinoma
Efficacy
Phase II
2-year local disease-free survival rate
safety, time to progression and 2-year overall survival rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
One TACE for one HCC. administrated dose; d cm= Dx10 mg
20 | years-old | <= |
Not applicable |
Male and Female
unresectable HCC with contraindication of local ablation therapy confirmed histologically or clinically by diagnostic imaging; no extrahepatic metastasis; tumor size less than 10 cm and tumor located in one segmental area or three subsegmental areas; no lingering effects of previous therapy; Eastern Cooperative Oncology Group performance status of 0 to 2; Child-Pugh classification A or B; maintenance of adequate bone marrow, kidney, cardiac function, and meeting clinical laboratory test criteria; age more than 20 years; life expectancy more than 3 months; and provision of written informed consent.
obvious development of feeding artery from an extrahepatic artery (e.g., inferior phrenic artery, inferior adrenal artery, internal mammary artery) to tumor; previous pancreato-biliary surgery or endoscopic sphincteropapillotomy; serious complications other than chronic hepatitis or liver cirrhosis; a history of allergy to iodine-containing agents or contrast media; extrahepatic metastasis; concomitant malignancy; active clinically serious infections; advanced arteriovenous shunt or arterioportal shunt; pregnant or lactating women, or women of childbearing potential; and other serious medical conditions.
20
1st name | |
Middle name | |
Last name | Hideyuki Nishiofuku |
Nara Medical University
Radiology
840 Shijo-cho Kashihara-city, Nara
0744-29-8900
hmn@naramed-u.ac.jp
1st name | |
Middle name | |
Last name | Hideyuki Nishiofuku |
Nara Medical University
Radiology
840 Shijo-cho Kashihara-city, Nara
0744-29-8900
hmn@naramed-u.ac.jp
Nara Medical University
Radiology, Nara Medical University
Self funding
NO
2016 | Year | 01 | Month | 31 | Day |
Published
Completed
2005 | Year | 10 | Month | 20 | Day |
2005 | Year | 11 | Month | 24 | Day |
2016 | Year | 01 | Month | 31 | Day |
2016 | Year | 02 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024024
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