UMIN-CTR Clinical Trial

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
Last 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
Email	akatou@yuuai.or.jp

Public contact
1st 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
Email	ochiai.tomishirocentral.hp@gmail.com

Sponsor
Institute	Tomishiro Central Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016053