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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001419
Receipt No. R000001731
Scientific Title The efficacy and safety of autologous gamma/delta T cell transfer therapy for esophageal cancer
Date of disclosure of the study information 2008/10/08
Last modified on 2019/04/16

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Basic information
Public title The efficacy and safety of autologous gamma/delta T cell transfer therapy for esophageal cancer
Acronym Autologous gamma/delta T cell therapy for esophageal cancer
Scientific Title The efficacy and safety of autologous gamma/delta T cell transfer therapy for esophageal cancer
Scientific Title:Acronym Autologous gamma/delta T cell therapy for esophageal cancer
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety of autologous gamma/delta T cell transfer therapy for recurrent or inoperable esophageal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Overall survival
Response rate
Survival rate (1 and 2 years)
Response of tumor-related markers
Immunological responses
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Gamma/delta T cells are injected on day0, day7, day14, day21, day35, day49, day63, day77.
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

Not applicable
Gender Male and Female
Key inclusion criteria Recurrent or inoperable esophageal cancer patients who meet the following:
- Pathological Diagnosed of esophageal cancer ;
- Diagnosis of recurrent esophageal cancer by imaging;
- Resistant to standard therapy, or resistant to or refuse DCF therapy;
- Life-expectancy is more than 3 months;
- Performance status is 0-1;
- No serious abnormality in heart, lung, bone marrow, liver, and renal functions.
Key exclusion criteria Patients who have:
- Pulmonary fibrosis or interstitial pneumonia, including their history or predisposition;
- Active enteritis;
- Active autoimmune diseases;
- Active infections;
- Other cancers;
- Other serious complications;
- Continuous systemic administration of steroids.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyuki Seto
Organization The University of Tokyo Hospital
Division name Gastrointestinal Surgery Division
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-3815-5411
Email seto-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Kakimi
Organization The University of Tokyo, Graduate School of Medicine
Division name Department of Immunotherapeutics
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5805-3161
Homepage URL
Email immunotherapy-admin@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2008 Year 10 Month 08 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 Terminated
Date of protocol fixation
2008 Year 09 Month 16 Day
Date of IRB
2008 Year 09 Month 16 Day
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 10 Month 08 Day
Last modified on
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001731

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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