UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007841 |
|---|---|
| Receipt number | R000008752 |
| Scientific Title | Phase I study of immuno-Cell therapy for advanced and recurrent esophageal squamous cell carcinoma |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2013/05/01 12:08:03 |
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Basic information
Public title
Phase I study of immuno-Cell therapy for advanced and recurrent esophageal squamous cell carcinoma
Acronym
Phase I study of immuno-Cell therapy for advanced and recuerent esophageal squamous cell carcinoma
Scientific Title
Phase I study of immuno-Cell therapy for advanced and recurrent esophageal squamous cell carcinoma
Scientific Title:Acronym
Phase I study of immuno-Cell therapy for advanced and recuerent esophageal squamous cell carcinoma
Region
| Japan |
Condition
Condition
Advanced and recurrent esophageal squamous cell carcinoma
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety and adverse event of immuno-Cell therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and responsibility
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
| Other |
Interventions/Control_1
Immunocell therapy using activated lymphocytes injections
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.Life expectancy of more than 12 weeks
2.Performance status 0-2
3.Age from 20 to 80 years
4.Adequate organ function
WBC:>2,000/ mm3 <15,000/mm3
Hb:>7.0 g/dl
Plt:>75,000/mm3
AST(GOT),ALT(GPT):<150 IU/l
T-Bil:<2.0mg / dl
Cr: <2.0mg/dl
5.Written informed consent
Key exclusion criteria
1.patient who has severe complication
2.patient who has bleeding tendency
3.patient who has active infectious disease
4.concomitant treatment with steroids
5.HBs antigen, HCV antibody, HIV antibody or HTLV-1 antibody is positive
6.patient who has activated autoimmune disease
7.patient who was judged to be unsuitable for this clinical trial
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Shimada |
Organization
Toho University Omori Medical Center
Division name
Department of Surgery
Zip code
Address
6-11-1 Omorinishi Ota-ku Tokyo Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Toho University School of Medicine
Division name
Department of Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | 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
| 2011 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
| 2012 | Year | 04 | Month | 26 | Day |
Last modified on
| 2013 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008752
