Unique ID issued by UMIN | UMIN000013378 |
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Receipt number | R000015605 |
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 |
Date of disclosure of the study information | 2014/06/30 |
Last modified on | 2018/09/10 18:08:27 |
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
The phase I clinical study about the combined therapy, natural killer (NK) cell therapy and IgG1 antibody to digestive cancer
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
The phase I clinical study about the combined therapy, natural killer (NK) cell therapy and IgG1 antibody to digestive cancer
Japan |
inoperable advance and recurrence stomach and colon cancer combined with IgG1 antibody in chemotherapy
Gastroenterology |
Malignancy
NO
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.
Safety,Efficacy
To assess the kind, grade and frequency of adverse event about combined therapy with the cultivated NK cell and IgG1 antibody.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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.
9
1st name | |
Middle name | |
Last name | Takeshi Ishikawa |
Kyoto Prefectural University of Medicine
Cancer ImmunoCell Regulation
465, Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan
075-251-5519
iskw-t@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Takeshi Ishikawa |
Kyoto Prefectural University of Medicine
Cancer ImmunoCell Regulation
465, Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan
075-251-5519
iskw-t@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
Kyoto Prefectural University of Medicine
Self funding
TAKARA BIO, INC
NO
2014 | Year | 06 | Month | 30 | Day |
Published
https://www.ncbi.nlm.nih.gov/pubmed/29388200
Completed
2014 | Year | 02 | Month | 28 | Day |
2014 | Year | 07 | Month | 01 | Day |
2014 | Year | 03 | Month | 09 | Day |
2018 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015605
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