Unique ID issued by UMIN | UMIN000010605 |
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Receipt number | R000012397 |
Scientific Title | Heating effect of miriplatin on transcatheter arterial chemoembolization therapy for hepatocellular carcinoma: a randomized controlled trial. |
Date of disclosure of the study information | 2013/04/27 |
Last modified on | 2018/06/21 10:20:25 |
Heating effect of miriplatin on transcatheter arterial chemoembolization therapy for hepatocellular carcinoma: a randomized controlled trial.
Randomized trial of heating effect of miriplatin on hepatocellular carcinoma.
Heating effect of miriplatin on transcatheter arterial chemoembolization therapy for hepatocellular carcinoma: a randomized controlled trial.
Randomized trial of heating effect of miriplatin on hepatocellular carcinoma.
Japan |
Hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To verify the effectiveness of heating of miriplatin on transcatheter arterial chemoembolization (TACE) therapy for hepatocellular carcinoma.
Efficacy
Tumor response
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
heating of miriplatin
non-heating of miriplatin
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically proven or clinically diagnosed hepatocellular carcinoma
2) Typical features of hepatocellular carcinoma as assessed by dynamic computed tomography or magnetic response imaging (ie, hypervascular with washout in the portal/venous phase)
3) No indication for surgical resection or liver transplantation
4) ECOG Performance Status 0-1
5) Adequate organ function
a) Neutrophil>=1500 /mm3
b) Hb>= 9.0 g/dL
c) PLT>= 50000 /mm3
d) T-Bil<= 3.0 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<= within 1.5 times of normal limit
6) Child-Pugh A or B
7) Adequate indication for TACE
8) Interval of at least 4 weeks between last treatment and start of present treatment
9) Life expectancy of at least 8 weeks
10) Written informed consent
1) Refractory pleural effusion or ascites
2) Encephalopathy
3) Concurrent disease
a) Serious hypertension
b) Severe heart disease
c) Acute myocardial infarction within 6 months prior to inclusion
d) Active double cancer
e) Severe mental disorder
f) Allergic reaction to iodine contrast material
g) Severe drug allergy
4) Intrahepatic or portal-caval shunts
5) Tumor thrombosis in main portal vein or vena cava
6) Pregnant and lactating females; females of childbearing age unless using effective contraception
7) Patients who are concluded to be inappropriate to participate in this study by their physicians
30
1st name | |
Middle name | |
Last name | Kohichiroh Yasui |
Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
1st name | |
Middle name | |
Last name |
Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
Kyoto Prefectural University of Medicine
None
Self funding
NO
2013 | Year | 04 | Month | 27 | Day |
Unpublished
Terminated
2013 | Year | 01 | Month | 28 | Day |
2013 | Year | 01 | Month | 28 | Day |
2013 | Year | 04 | Month | 27 | Day |
2018 | Year | 06 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012397
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