UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004714 |
|---|---|
| Receipt number | R000005602 |
| Scientific Title | Phase I clinical study with 5 peptides vaccination in HLA-A2402-positive advanced-stage esophageal cancer patients |
| Date of disclosure of the study information | 2010/12/14 |
| Last modified on | 2012/06/14 18:06:00 |
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Basic information
Public title
Phase I clinical study with 5 peptides vaccination in HLA-A2402-positive advanced-stage esophageal cancer patients
Acronym
Clinical study with multi-peptides vaccination in esophageal cancer patients
Scientific Title
Phase I clinical study with 5 peptides vaccination in HLA-A2402-positive advanced-stage esophageal cancer patients
Scientific Title:Acronym
Clinical study with multi-peptides vaccination in esophageal cancer patients
Region
| Japan |
Condition
Condition
chemotherapy-resistance unresectable esophageal cancer
Classification by specialty
| Gastroenterology | Surgery in general | Gastrointestinal surgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
safety
Key secondary outcomes
immunological responce
tumor regression
survival time
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
| Medicine | Vaccine |
Interventions/Control_1
URLC10,TTK,KOC1,VEGFR1,VEGFR2-derived peptide vaccine
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)pathologicaly diagnosed esophagal squamous cell carcinoma
2)unresectable and refractory for standard chemotherapy
3)Performance status(ECOG) 0,1,2
4)obtains lesionthat can be evaluated by RECIST
5)more than 4 weeks after prior therapy
6)WBC >=2000, <=15000
Platelet>=50000
Total Bilirubin<=3.3
Creatinine<=2.2
7)HLA-A*24:02
8)obtains writen informed consent
Key exclusion criteria
1)severe comorbidity(cardiovascular disease, respiratory disease, infectious disease)
2)pregnant woman
3)systemic administration of immunosuppressant
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soji Ozawa |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
TEL
0463-93-1121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Nakui |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
143 Shimoksuya, Isehara, Kanagawa, Japan
TEL
0463-93-1121
Homepage URL
http://eso-ges.med.u-tokai.ac.jp/index.html
nakui@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Research and Study Program of Tokai University Educational System General Research Organization
2009 Tokai University School of Medicine Research Aid
Organization
Division
Category of Funding Organization
Other
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
東海大学医学部付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 14 | 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
| 2008 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2011 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 13 | Day |
Last modified on
| 2012 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005602
| 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 |
