UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000854 |
|---|---|
| Receipt number | 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 10:56:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
immunotherapy-admin@umin.ac.jp
Sponsor or person
Institute
University of Tokyo, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001026
