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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004660
Receipt No. 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

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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
Email 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
Email hiroakitan@med.osaka-cu.ac.jp

Sponsor
Institute Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005551

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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