UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Chemotherapy-naive unresectable or recurrent pancreatic cancer
Classification by specialty	Hematology and clinical oncology Hepato-biliary-pancreatic surgery
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	Medicine
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	20 years-old <=
Age-upper limit	Not applicable
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
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
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yoshiyuki Middle name Last name YAMAGUCHI
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
Email	shogo@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Yoshiyuki Middle name Last name YAMAGUCHI
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
Email	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
Email	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	2020 Year 10 Month 01 Day

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	2020 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 01 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 04 Day
Last modified on	2020 Year 09 Month 04 Day

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

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