UMIN-CTR Clinical Trial

Basic information
Public title	The phase I clinical study about the combined therapy, high purity natural killer (NK) cell therapy and IgG1 antibody to inoperable advance and recurrence digestive cancer
Acronym	The phase I clinical study about the combined therapy, natural killer (NK) cell therapy and IgG1 antibody to digestive cancer
Scientific Title	The phase I clinical study about the combined therapy, high purity natural killer (NK) cell therapy and IgG1 antibody to inoperable advance and recurrence digestive cancer
Scientific Title:Acronym	The phase I clinical study about the combined therapy, natural killer (NK) cell therapy and IgG1 antibody to digestive cancer
Region	Japan

Condition
Condition	inoperable advance and recurrence stomach and colon cancer combined with IgG1 antibody in chemotherapy
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The safety about the repeated dose of cultivated NK cell to digestive cancer patient who had failed standard treatment was checked in the our previous phase I clinical study, so in this study, main purpose is to evaluate the safety of the combined therapy of the cultivated NK cell, chemotherapy and IgG1 antibody.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To assess the kind, grade and frequency of adverse event about combined therapy with the cultivated NK cell and IgG1 antibody.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous transfer of autologous NK cells. Dose-escalation study with three groups 1)5x10*8 cells 3 patients 2)1x10*9 cells 3 patients 3)2x10*9 cells 3 patients
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Histologically confirmed gastric or colon cancer. 2) Patients informed diagnosis of their disease 3) In gastric cancer, patient must be cared with Capecitabine + Cisplatin + Trastuzumab or S-1 + Cisplatin + Trastuzumab chemotherapy regimen. In colon cancer, patient must be cared with Capecitabine + Oxaliplatin + Cetuximab or S-1 + Oxaliplatin + Cetuximab chemotherapy regimen. 4) Aged from 20 to 80 years 5) Grade 0 to 2 in performance status (ECOG). 6) Lasting at least four weeks since previous cell infusion therapy. 7) Sufficient functions of major organ. 8) Expected to be alive at least four months after informed consent. 9) Having written informed consent.
Key exclusion criteria	1) Presence of uncontrolled infection 2) Hypersensitivity or autoimmune disease requiring treatments 3) Presence of severe comlications(malignant hypertension, congestive heart failure, severe coronary disease, history of myocardial infarction less than six months prior, pulmonary fibrosis or active interstitial pneumonitis) 4) Inappropriate patients for this study due to severe complications. 5) Patient who cannot undergo enhanced CT scan or MRI due to some reason such as allergy for contrast media or renal dysfunction. 6) Active other malignancy, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable. 7) Medical history of severe hypersensitivity. 8) Severe mental impairment 9) Pregnant or lactating women 10) Patient with HBV, HCV, HIV, HTLV-1 or syphilis infection 11) Inappropriate patients for study judged by the physicians. 12) Patient with bad NK cell cultivation.
Target sample size	9

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeshi Ishikawa
Organization	Kyoto Prefectural University of Medicine
Division name	Cancer ImmunoCell Regulation
Zip code
Address	465, Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan
TEL	075-251-5519
Email	iskw-t@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takeshi Ishikawa
Organization	Kyoto Prefectural University of Medicine
Division name	Cancer ImmunoCell Regulation
Zip code
Address	465, Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan
TEL	075-251-5519
Homepage URL
Email	iskw-t@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	TAKARA BIO, INC
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	2014 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/29388200
Number of participants that the trial has enrolled
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 02 Month 28 Day
Date of IRB
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 03 Month 09 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015605

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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