UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002394 |
|---|---|
| Receipt number | 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 08:57:17 |
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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
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
ytatsuya@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002941
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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