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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017508
Receipt No. R000020297
Scientific Title Study of blood platinum concentration transition in TACE using the cisplatin containing Hepasufhia
Date of disclosure of the study information 2015/05/12
Last modified on 2016/05/16

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Basic information
Public title Study of blood platinum concentration transition in TACE using the cisplatin containing Hepasufhia
Acronym CDDP-Hepasphia pharmacokinetics study
Scientific Title Study of blood platinum concentration transition in TACE using the cisplatin containing Hepasufhia
Scientific Title:Acronym CDDP-Hepasphia pharmacokinetics study
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Objective is measured cisplatin elution amount from Hepasufhia using the blood platinum concentration transition.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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 Device,equipment Maneuver
Interventions/Control_1 DEB-TACE using the cisplatin (50mg)containing Hepasufhia (50-100 micro m).
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 No indication for surgical resection.
2 Histologically or clinically cobfirmed hepatocellular carcinoma.
3 Ages 30 to 80 years old.
4 Life expectancy is more than 3months
5 Written informed consent was obtained.
6 ECOG performance status is 0 or 1.
7 Sufficient function of main organ (born marrow, kidney, heart ) and conditions filled the following criteria.
Key exclusion criteria 1 Previous operation or RFA or PEIT within 1 year.
2 Extrahepatic metastasis or lymph nodes metastasis.
3 Active cancer of the other organs.
4 Active double cancers.
5 Concurrent infections(without hepatitis virus).
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 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nagamatsu
Organization Yame General Hospital
Division name Department of Hepatology
Zip code
Address 540-2,Takatsuka,Yame,Fukuoka,834-0034
TEL 0943-23-4131
Email ymhp0389@yamehp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Kooka
Organization Yame General Hospital
Division name Department of Hepatology
Zip code
Address 540-2,Takatsuka,Yame,Fukuoka,834-0034
TEL 0943-23-4131
Homepage URL
Email ymhp0389@yamehp.jp

Sponsor
Institute Yame General Hospital
Institute
Department

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
Email

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

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Open public recruiting
Date of protocol fixation
2015 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 11 Day
Last modified on
2016 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020297

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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