UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013794 |
|---|---|
| Receipt number | R000016053 |
| Scientific Title | Clinical Study of the GEM Combined Use Gamma Delta T Immune-Cells Treatment an Excision Impossible Paccreatic Cancer |
| Date of disclosure of the study information | 2014/06/02 |
| Last modified on | 2019/04/30 11:51:33 |
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Basic information
Public title
Clinical Study of the GEM Combined Use Gamma Delta T Immune-Cells Treatment an Excision Impossible Paccreatic Cancer
Acronym
Clinical Study of the GEM Combined Use Gamma Delta T Immune-Cells Treatment an Excision Impossible Paccreatic Cancer
Scientific Title
Clinical Study of the GEM Combined Use Gamma Delta T Immune-Cells Treatment an Excision Impossible Paccreatic Cancer
Scientific Title:Acronym
Clinical Study of the GEM Combined Use Gamma Delta T Immune-Cells Treatment an Excision Impossible Paccreatic Cancer
Region
| Japan |
Condition
Condition
Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of progression-free survival of gamma delta T immune cell therapy in combination with GEM for unresectable pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free Survival
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gamma Delta T Immune-Cells
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
1) The patients that the diagnosis of the cancer was obtained by histological diagnosis or cytodiagnosis in principle.
2)An outpatients over 20 years old.
3) Performance States (PS) is 0 to 3.
4) The good prognosis will be expected 3 months or more until administration starting point.
5) In principle, keep major organ function is kept as follows;
Number of White Blood Cell>4,000/mm3, <12,000/mm3.
Number of neutrophil>2,000/mm3.
Platelet count>100,000/mm3.
Number of hemoglobin>10.0g/dL.
Serum GOP and GPT< upper limits of institution x 2.
Total serum bilirubin<1.5mg/dL.
Serum creatinine<1.5mg//dL.
But in the case of not meet a condition, reason came from existing disease(Cancer). Lead principal investigator can add those patients to this study by his judgment.
6) The patient that agreement was obtained in a document than the person himself in response to a name of disease condition notice.
7) Women; Pregnant possibility is denied by surgery, radiation or menopause, or possibility of pregnant can be reduced by the use of the approved antifertility method from the administration starting point to after 3 month of study finished.
Key exclusion criteria
1) The patients with autoimmune disease
2) The patients with complications having poor control. (An infection, diabetes, hypertension, ischemic heart disease, cerebral infraction, etc.).
3) The patients egnancy nursing mother and the pregnant likelihood(possibility).
4) The patients history of the drug allergy.
5) The patients with double cancer.
6) The patients with HIV antibody-possitive.
7) The patients with locally advanced pancreatic cancer in need of radiotherapy .
8) Other, the patients is judged inadequate by research contact person
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Atsunaga |
| Middle name | |
| Last name | Katou |
Organization
Tomishiro Central Hospital
Division name
Department of Internal Medicine
Zip code
9010243
Address
25 Ueta, Tomigusuku-shi, Okinawa, Japan
TEL
098-850-3811
akatou@yuuai.or.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Ochiai |
Organization
Tomishiro Central Hospital
Division name
Clinical Study Support Center
Zip code
9010243
Address
Kanehiro Sangyo 2nd Bldg #202, 293-1 Gibo, Tomigusuku-shi, Okinawa, 901-0244, Japan
TEL
098-891-6375
Homepage URL
ochiai.tomishirocentral.hp@gmail.com
Sponsor or person
Institute
Tomishiro Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Okinawa Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okinawa Red Cross Hospital
Urasoe Sogo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yuaikai research ethics committee
Address
25 Ueta, Tomigusuku-shi, Okinawa, Japan
Tel
098-850-3811
chiken@yuuai.or.jp
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
社会医療法人友愛会 豊見城中央病院
沖縄赤十字病院
社会医療法人仁愛会 浦添総合病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 02 | 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
11
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
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 23 | Day |
Last modified on
| 2019 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016053
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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