Unique ID issued by UMIN | UMIN000021827 |
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Receipt number | R000025165 |
Scientific Title | Clinical efficacy of nab-PTX+GEM chemotherapy plus zoledronate- activated autologous killer lymphocytes (ZAK cells) in patients with unresectable or recurrent pancreas cancer |
Date of disclosure of the study information | 2016/04/07 |
Last modified on | 2023/04/13 12:30:05 |
Clinical efficacy of nab-PTX+GEM chemotherapy plus zoledronate- activated autologous killer lymphocytes (ZAK cells) in patients with unresectable or recurrent pancreas cancer
PCaGNZAK
Clinical efficacy of nab-PTX+GEM chemotherapy plus zoledronate- activated autologous killer lymphocytes (ZAK cells) in patients with unresectable or recurrent pancreas cancer
PCaGNZAK
Japan |
Chemotherapy-naive unresectable or recurrent pancreatic cancer
Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Malignancy
NO
PFS: progression free survival
Safety,Efficacy
PFS: progression free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Nab-PTX+GEM+Zolrdronate-activated killer cells
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Histologically-defined panreatic cancer
2) Measurable lesion
3) un-treated
4) Age 20-80
5) PS 0-2
6) Estimated prognosis >= 3 months
7) Sufficient organ function
WBC>4,000/mm3, <12,000/mm3
NE>2,000/mm3
PLT>100.000/mm3
Hg>10.0g/dl
GOT/GPT<Normal range x 2
Bil<1.5mg/dl
Creat<1.5mg/dl
8) Written informed consent
9) No pregnancy
1) Autoimmune disease
2) Uncontrollable complications including
infection, diabetes, hypertension, ischemic heart disease, cerebral infarction, interstitial pneumonitis, cancer pain
3) Pregnancy
4) Allergy
5) General symptoms including dyspnea, jaundice, edema, effusions, clamp, paralysis, fracture, difficult for out-patient
6) Double cancer
7) Other cancer treatment
8) Steroid or immunosuppressive agents
9) Other unacceptable reasons
60
1st name | Yoshiyuki |
Middle name | |
Last name | YAMAGUCHI |
Kawasaki Medical School
Department of Clinical Oncology
701-0192
Matsushima 577, Kurashiki, Okayama 701-0192, Japan
086-462-1111
shogo@med.kawasaki-m.ac.jp
1st name | Yoshiyuki |
Middle name | |
Last name | YAMAGUCHI |
Kawasaki Medical School
Department of Clinical Oncology
701-0192
Matsushima 577, Kurashiki-city, Okayama, 701-0192 Japan
086-462-1111
shogo@med.kawasaki-m.ac.jp
Kawasaki Medical School
Department of Clinical Oncology
Kawasaki Medical School
Department of Clinical Oncology
Self funding
IRB for Regenerative Medicine of Kawasaki Medical School Hospital
577 Matsushima Kurashiki
086-462-1111
hsyomu@med.kawasaki-m.ac.jp
NO
2016 | Year | 04 | Month | 07 | Day |
Unpublished
60
Terminated
2016 | Year | 09 | Month | 12 | Day |
2016 | Year | 09 | Month | 12 | Day |
2016 | Year | 10 | Month | 17 | Day |
2023 | Year | 03 | Month | 31 | Day |
2016 | Year | 04 | Month | 07 | Day |
2023 | Year | 04 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025165
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