Unique ID issued by UMIN | UMIN000002073 |
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Receipt number | R000002358 |
Scientific Title | Phase II study of combination therapy of cisplatin suspension in lipiodol and 5-fluorouracil hepatic arterial infusion for advanced HCC |
Date of disclosure of the study information | 2009/07/01 |
Last modified on | 2011/06/16 20:01:11 |
Phase II study of combination therapy of cisplatin suspension in lipiodol and 5-fluorouracil hepatic arterial infusion for advanced HCC
The study of NFP for advanced HCC
Phase II study of combination therapy of cisplatin suspension in lipiodol and 5-fluorouracil hepatic arterial infusion for advanced HCC
The study of NFP for advanced HCC
Japan |
Hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
This study assessed the efficacy of CDDP on lipiodol suspension with 5-FU for patients with HCC measuring more than 5cm in diameter and portal vein tumor thrombosis.
Safety,Efficacy
Phase II
Progrssion free survival
Overall survival
response evaluation
complicasion
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
hospitalization therapy administration via the implanted port of Cisplatin/lipiodol suspension(50mg/body,ia,day1,8) and 5-FU(1250mg/body/day, cia day1-5,8-12) into the hepatic artery every two weeks.
outpatient therapy : The case that chemotherapy by the hospitalization finished,leaves the hospital if possible.
Administration via the implanted port of Cisplatin/lipiodol suspension(10~50mg/body,ia,day1)and 5-FU(500~1250mg/body/day,cia,day1-5)into the hepatic artery every two weeks.Repeat 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 branch) or multinodular tumor and maximum tumor size is >=50mm.
4.Ages 30 to 80 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>=2,000/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 or CCr>=50mL/min
Ejection fraction>=45%
PaO2>=60mmHg
8.Written informed consent was obtained
1.previous chemotherapy or TAE
2.Previous operation or RFA or PEIT within one year
3.Extrahepatic metastasis or 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.
50
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
2009 | Year | 07 | Month | 01 | Day |
Published
52 cases
PFS=8.5 months
MST=27 months
Tumor Response
response rate=75%
Completed
2007 | Year | 05 | Month | 14 | Day |
2007 | Year | 05 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 05 | Month | 01 | Day |
2011 | Year | 05 | Month | 01 | Day |
2009 | Year | 06 | Month | 12 | Day |
2011 | Year | 06 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002358
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