Unique ID issued by UMIN | UMIN000003302 |
---|---|
Receipt number | R000003995 |
Scientific Title | Phase I study of hepatic arterial infusion chemotherapy with Miriplatin and 5-fluorouracil(MiF) for advanced HCC |
Date of disclosure of the study information | 2010/04/01 |
Last modified on | 2012/03/12 14:40:53 |
Phase I study of hepatic arterial infusion chemotherapy with Miriplatin and 5-fluorouracil(MiF) for advanced HCC
Phase I study of MiF for advanced HCC
Phase I study of hepatic arterial infusion chemotherapy with Miriplatin and 5-fluorouracil(MiF) for advanced HCC
Phase I study of MiF for advanced HCC
Japan |
Hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
This study assessed the safety and efficacy of MiF therapy for advavced HCC(not indicated transplantation, hepatic resection, TFA, TAE)
Safety,Efficacy
Phase I
complication
response evaluation
overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
inpatient therapy:administration via the implanted port of Miriplatin(65mg/m2,ia,day1) and 5-FU(850mg/m2,cia,day1-5and 8-12) into the hepatic artery.
outpatient therapy:administration via the implanted port of Mireplatin(35mg/m2,ia) and 5-FU(500mg/m2,cia) into the hepatic artery every two weeks.Repeat 5-10 courses.
30 | years-old | <= |
80 | years-old | > |
Male and Female
1.Histologically or clinically confirmed hepatocellular carcinoma.
2. No indication for transplantation or surgical resection.
3.Portal vein tumor thrombosis (main trunk or first,second branch)or multinodular tumor and maximum tumor size is >=50mm.
4.Ages 30 to 79 years old.
5.EOCG performance status is 0 or 1.
6.Life expectancy is more than 3 months.
7.Sufficient function of main organ(bone marrow,kidney,heart)and conditions filled the following criteria.
WBC>=2000/mm3
Hb>=8.5g/dL
Plt>=50,000/mm3
Child-Pugh score <9
T-bil=<2.0mg/dL
Without uncontrolled ascites and hepatic encephalopathy.
S-Cr=<1.5mg/dL
Ejection fraction>=45%
PaO2>=60mmHg
8.Written informed consent was obtained.
1.Previous chemothrapy or TAE
2.Previous operation or RFA or PEIT within 6 months.
3.Extrahepatic metastasis or lymph nodes metastasis.
4.Concurrent infections(without hepatitis virus)
5.Active double cancers
6.Medical history of severe hypersensitivity.
7.Pregnant,lacting women or women with suspected pregnancy.
8.Inappropriate patients for this study judged by physicians.
10
1st name | |
Middle name | |
Last name | Michio Sata |
Kurume university School of Medicine
Division of Gastroenterology
67,Asahi-machi,Kurume-city,Fukuoka,830-0011,Japan
0942-31-7561
1st name | |
Middle name | |
Last name | Hiroaki Nagamatsu |
Yame General Hospital
Department of Gastroenterology and Hepatology
540-2,Takatsuka,Yame-city,Fukuoka,834-0034
0943-23-4131
ymhp0389@yamehp.jp
Division of Gastroenterology,Kurume University School of Medicine
None
Other
NO
公立八女総合病院(福岡県)
2010 | Year | 04 | Month | 01 | Day |
Partially published
CR/PR/SD/PD:1/5/3/1
OS
6 months:90% , 12 manths:48%
MST:297 days
Safety: no ploblem
Completed
2010 | Year | 02 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2010 | Year | 03 | Month | 09 | Day |
2012 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003995