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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004006
Receipt No. R000004809
Scientific Title Phase I clinical study of peptide vaccine using Cancer-Testis antigen against advanced esophageal cancer
Date of disclosure of the study information 2010/08/06
Last modified on 2014/05/30

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Basic information
Public title Phase I clinical study of peptide vaccine using Cancer-Testis antigen against advanced esophageal cancer
Acronym CT antigen vaccine to advanced esophageal cancer
Scientific Title Phase I clinical study of peptide vaccine using Cancer-Testis antigen against advanced esophageal cancer
Scientific Title:Acronym CT antigen vaccine to advanced esophageal cancer
Region
Japan

Condition
Condition Advanced esophageal squamous cell carcinoma refractory to standard therapeutic modality
Classification by specialty
Medicine in general Gastroenterology Surgery in general
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and adverse event.
This clinical study collaborated with Prof. Yusuke Nakamura, Institute of Medical Science, the University of Tokyo.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes To evaluate the safety and adverse event.
Key secondary outcomes

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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1)Performance status 0-2
(2Age 20 to 80 years-old
(3)WBC<=2000,>=15000
PLT<=75000
GOT>=150
GPT>=150
T-bil>=2.0
Cr>=2.0
(4)HLA-A2402 positive
(5)Obtains written informed concent
Key exclusion criteria (1)Pregnant woman
(2)Lactating woman
(3)Severe bleeding tendency
(4)Uncontrolled infection
(5)Concomitant treatment with steroids
(6)patients who are judged inappropriate for the entry into study by the investigator
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Shimada
Organization Toho University School of Medicine
Division name Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Yajima
Organization Toho University School of Medicine
Division name Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL
Homepage URL
Email

Sponsor
Institute Toho University
Institute
Department

Funding Source
Organization Toho University
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

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 06 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
2010 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 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
2010 Year 08 Month 06 Day
Last modified on
2014 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004809

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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