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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041683 |
Receipt No. | R000047584 |
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 | 2020/10/01 |
Last modified on | 2020/09/04 |
Basic information | ||
Public title | Clinical efficacy of nab-PTX+GEM chemotherapy plus zoledronate- activated autologous killer lymphocytes (ZAK cells) in patients with unresectable or recurrent pancreas cancer | |
Acronym | PCaGNZAK | |
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 | |
Scientific Title:Acronym | PCaGNZAK | |
Region |
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Condition | |||
Condition | Chemotherapy-naive unresectable or recurrent pancreatic cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | PFS: progression free survival |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | PFS: 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 |
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Interventions/Control_1 | Nab-PTX+GEM+Zolrdronate-activated killer 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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Histologically-defined panreatic cancer
2) Measurable lesion 3) un-treated 4) Age =<20 5) PS 0-1 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 |
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Key exclusion criteria | 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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kawasaki Medical School | ||||||
Division name | Department of Clinical Oncology | ||||||
Zip code | 701-0192 | ||||||
Address | Matsushima 577, Kurashiki, Okayama 701-0192, Japan | ||||||
TEL | 086-462-1111 | ||||||
shogo@med.kawasaki-m.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kawasaki Medical School | ||||||
Division name | Department of Clinical Oncology | ||||||
Zip code | 701-0192 | ||||||
Address | Matsushima 577, Kurashiki, Okayama 701-0192, Japan | ||||||
TEL | 086-462-1111 | ||||||
Homepage URL | |||||||
shogo@med.kawasaki-m.ac.jp |
Sponsor | |
Institute | Kawasaki Medical School
Department of Clinical Oncology |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | IRB for Regenerative Medicine of Kawasaki Medical School Ho spital |
Address | 577 Matsushima, Kurashiki, 701-0192, JAPAN |
Tel | 086-462-1111 |
hsyomu@med.kawasaki-m.ac.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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047584 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |