UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intraperitoneal autologous gamma/delta T cell therapy for refractory gastric cancer with ascites.
Title of the study (Brief title)	Autologous gamma/delta T cell therapy for gastric cancer with ascites.
Region	Japan

Condition
Condition	Primary gastric adenocarcinoma
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate safety on intraperitoneal injection of autologous gamma/delta T cell for refractory gastric cancer with ascites.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Safety : Adverse events
Key secondary outcomes	Pharmacokinetics Overall survival Progression-free survival Immunological responses

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Zoledronic acid hydrate is administered on day-1, 6, 13, 20 and autologous gamma/delta T cells are intraperitoneally injected on day0, day7, day14, day21.
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	Primary gastric adenocarcinoma patients who meet the following: - Resistant to standard therapies or rejection of them; - Peritoneal dissemination and capable of removing ascites in safety; - Performance status is 0-2; - 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 and/or gastrointestinal bleeding; - Active autoimmune diseases; - Active infections; - Other cancers; - Brain metastasis; - Continuous systemic administration of steroids.
Target sample size	15

Research contact person
Name of lead principal investigator	Yasuyuki Seto
Organization	The University of Tokyo Hospital
Division name	Gastrointestinal Surgery Division
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	Kazuhiro Kakimi
Organization	The University of Tokyo, Graduate School of Medicine
Division name	Department of Immunotherapeutics
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	Tokyo Metropolitan Bokutoh Hospital
Name of secondary funｄer(s)

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	東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 22 Day
Anticipated trial start date	2010 Year 08 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3987085/
Results
Other related information

Management information
Registered date	2010 Year 08 Month 30 Day
Last modified on	2018 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004959