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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002394
Receipt No. R000002941
Scientific Title A multicenter study of new anticancer agent for patients with advanced hepatocellular carcinoma : efficacy and safety
Date of disclosure of the study information 2009/09/01
Last modified on 2013/09/02

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Basic information
Public title A multicenter study of new anticancer agent for patients with advanced hepatocellular carcinoma : efficacy and safety
Acronym A multicenter study of new anticancer agent for patients with advanced hepatocellular carcinoma : efficacy and safety
Scientific Title A multicenter study of new anticancer agent for patients with advanced hepatocellular carcinoma : efficacy and safety
Scientific Title:Acronym A multicenter study of new anticancer agent for patients with advanced hepatocellular carcinoma : efficacy and safety
Region
Japan

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

Objectives
Narrative objectives1 To identify therapeutic efficacy and safety of new-anticancer agent for patients with advanced hepatocellular carcinoma, and investigate proper patient selection, protocol and prevention of adverse effect
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety of new anti-cancer agents : Incidence of adverse event
Key secondary outcomes Efficacy of new anti-cancer agents : Overall survival, progression-free survival, time to disease progression, overall response rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Hepatocellular carcionoma confirmed by dynamic CT or dynamic MRI, or histologically confirmed hepatocellular carcinoma

2) Unresectable advanced hepatocellular carcinoma treated by new anticancer agent

3) Written informed consents
Key exclusion criteria 1) Contraindication of new anticancer agent
2) The investigator consider not suitable for the study
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Kaneko
Organization Kanazawa University Hospital
Division name Department of Gastrenterology
Zip code
Address 13-1 Takara-Machi, Kanazawa, Ishikawa
TEL 076-265-2233
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Yamashita
Organization Kanazawa University Hospital
Division name Department of Gastrenterology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2861
Homepage URL
Email ytatsuya@m-kanazawa.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 金沢大学附属病院(石川県)
愛媛大学附属病院(愛媛県)
鳥取大学附属病院(鳥取県)
千葉大学附属病院(千葉県)
山口大学附属病院(山口県)
大阪大学附属病院(大阪府)
杏林大学附属病院(東京都)
東北大学附属病院(宮城県)
昭和大学附属病院(東京都)
兵庫医科大学附属病院(兵庫県)
近畿大学附属病院(大阪府)
岐阜大学附属病院(岐阜県)
岡山大学附属病院(岡山県)
虎ノ門病院(東京都)
久留米大学附属病院(福岡県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 01 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 Completed
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study, non-random sampling

Management information
Registered date
2009 Year 08 Month 27 Day
Last modified on
2013 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002941

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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