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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000854
Receipt No. R000001026
Scientific Title Clinical study on efficacy and safety of autologous gamma/delta T cell transfer therapy after pulmonary metastasectomy of colorectal cancer
Date of disclosure of the study information 2007/10/18
Last modified on 2014/07/18

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Basic information
Public title Clinical study on efficacy and safety of autologous gamma/delta T cell transfer therapy after pulmonary metastasectomy of colorectal cancer
Acronym Clinical study of gamma/delta T cell therapy after pulmonary metastasectomy of colorectal cancer
Scientific Title Clinical study on efficacy and safety of autologous gamma/delta T cell transfer therapy after pulmonary metastasectomy of colorectal cancer
Scientific Title:Acronym Clinical study of gamma/delta T cell therapy after pulmonary metastasectomy of colorectal cancer
Region
Japan

Condition
Condition lung metastasis of colorectal cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of autologous gamma/delta T cell transfer therapy after pulmonary metastasectomy of colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relapse rate(1 and 2 years)
Key secondary outcomes Relapse free survival
Overall survival
Survival rate(1 and 2 years)
Response of tumor-related markers
Immunological response
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
Medicine
Interventions/Control_1 Gannma/delta T cells are injected on day0, day7, day14, day21, day28, day35, day42, day49.
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 Patients with lung metastasis of colorectal cancer:
- Lesion(s) is(are) to be macroscopically completely resectable;
- Life-expectancy is more than 3 months;
- Performance status is 0-1;
- No serious abnormality in bone marrow, liver, and renal functions.

Key exclusion criteria Patients who have
- Pulmonary fibrosis or interstitial pneumonia, or their history, or predisposition to them;
- Active enteritis, autoimmune diseases, and/or infections
- Double cancer;
- Other serious complications;
- Continuous systemic administration of steroids.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Nakajima
Organization University of Tokyo, Graduate School of Medicine
Division name Department of Cardiothoracic surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Kakimi
Organization 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 University of Tokyo, Graduate School of Medicine
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
2007 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.celltherapyjournal.org/article/S1465-3249(12)00101-6/abstract
Number of participants that the trial has enrolled
Results
Cytotherapy. 2013 Apr;15(4):481-91
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
2007 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2014 Year 05 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
2007 Year 10 Month 18 Day
Last modified on
2014 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001026

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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