UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004660 |
|---|---|
| Receipt number | R000005551 |
| Scientific Title | Pjase I study of peptide vacicination using eitope petide derived from novel oncoantigen for patients with metastatic or recuurent cholangiocarcinoma |
| Date of disclosure of the study information | 2010/12/02 |
| Last modified on | 2016/08/09 13:10:11 |
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Basic information
Public title
Pjase I study of peptide vacicination using eitope petide derived from novel oncoantigen for patients with metastatic or recuurent cholangiocarcinoma
Acronym
Phase I study of peptide vaccination for patients with cholangiocarcinoma
Scientific Title
Pjase I study of peptide vacicination using eitope petide derived from novel oncoantigen for patients with metastatic or recuurent cholangiocarcinoma
Scientific Title:Acronym
Phase I study of peptide vaccination for patients with cholangiocarcinoma
Region
| Japan |
Condition
Condition
cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the safty of cancer specific antigen -derived peptide vaccines and gemcitabine for cholangiocarcinoma. This is clinical study collaborated with Professor Yusuke Nakamura, Institute of Medical Science, the University of Tokyo.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluation of safety of peptide vaccine and gemcitabine
Key secondary outcomes
Immunological Response, Respoense rate
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
| Vaccine |
Interventions/Control_1
peptide vaccination
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Despite former therapy, Recurrence or being excision impossible cholangiocarcinoma case which desires vaccine therapy.
2) Age between 20 and 85
3) HLA-A*2402
4)Performance status (ECOG) 0 or 1
5)obtains lesion which can be evaluated by RECIST
6)more than 4 weeks after prior therapy
7)without dysfunction of multiple major organs
8) more than 3 months of prognosis
9) obtains written informed consent
Key exclusion criteria
1.severe ischemic heart disease and arrythmia
2. pregnant woman
4. severe active infection disease
5. pateients required administration of steroids
6.multiple cancer patients
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuya Yamada |
Organization
Osaka City University Graduate School
Division name
Surgical Oncology
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
06-6645-3838
nyamada@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Tanaka |
Organization
Osaka City Osaka CIty University Graduate School
Division name
Surgical Oncology
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
06-6645-3838
Homepage URL
hiroakitan@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
大阪市立大学付属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 02 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 02 | Day |
Last modified on
| 2016 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005551
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
