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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029281
Receipt No. R000027659
Scientific Title Feasibility and efficacy of downstaging treatment for hepatocellula carcinoma over the Milan Criteria.
Date of disclosure of the study information 2017/09/27
Last modified on 2017/09/27

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Basic information
Public title Feasibility and efficacy of downstaging treatment for hepatocellula carcinoma over the Milan Criteria.
Acronym Downstaging treatment for Over Milan HCC.
Scientific Title Feasibility and efficacy of downstaging treatment for hepatocellula carcinoma over the Milan Criteria.
Scientific Title:Acronym Downstaging treatment for Over Milan HCC.
Region
Japan

Condition
Condition HCC
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Feasibility and safety of downstaging
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse event
Key secondary outcomes effectiveness
achievement rate of transplantation

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 Maneuver
Interventions/Control_1 Treatment for HCC, TACE, RFA, sorafenib, surgery, PEIT
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1,Not greater than 65, not less than Child B
2, HCC of over Milan criteria
3, No distant metastasis, no vascular invasion, tumor size not greater than 8cm.
4, Child wihin 11
5, Patient agreement
Key exclusion criteria 1, Allergy to contrast agent
2, No agreement
3, Active infetion
4, Active double cancer.
5, Active gastrointestinal ulcer
6, Severe comorbidity
7, Severe mental disorder
8, Severe drug allergy
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinoda Masahiro
Organization Keio university school of medicine
Division name Surgery
Zip code
Address Shinanomachi 35 Shinjuku Tokyo Japan
TEL 0333531211
Email masa02114@z6.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinoda Masahiro
Organization Keio university school of medicine
Division name Surgery
Zip code
Address Shinanomachi 35 Shinjuku Tokyo Japan
TEL 0333531211
Homepage URL
Email masa02114@z6.keio.jp

Sponsor
Institute Keio university school of medicine
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
2017 Year 09 Month 27 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 15 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
2017 Year 09 Month 25 Day
Last modified on
2017 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027659

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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