UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Phase I study of hepatic arterial infusion chemotherapy with Miriplatin and 5-fluorouracil(MiF) for advanced HCC
Acronym
Phase I study of MiF for advanced HCC
Scientific Title
Phase I study of hepatic arterial infusion chemotherapy with Miriplatin and 5-fluorouracil(MiF) for advanced HCC
Scientific Title:Acronym
Phase I study of MiF for advanced HCC
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study assessed the safety and efficacy of MiF therapy for advavced HCC(not indicated transplantation, hepatic resection, TFA, TAE)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
complication
Key secondary outcomes
response evaluation
overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Sata |
Organization
Kurume university School of Medicine
Division name
Division of Gastroenterology
Zip code
Address
67,Asahi-machi,Kurume-city,Fukuoka,830-0011,Japan
TEL
0942-31-7561
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nagamatsu |
Organization
Yame General Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
540-2,Takatsuka,Yame-city,Fukuoka,834-0034
TEL
0943-23-4131
Homepage URL
ymhp0389@yamehp.jp
Sponsor or person
Institute
Division of Gastroenterology,Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
公立八女総合病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
CR/PR/SD/PD:1/5/3/1
OS
6 months:90% , 12 manths:48%
MST:297 days
Safety: no ploblem
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 09 | Day |
Last modified on
| 2012 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003995
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