UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021827
Receipt No. 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 2017/12/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Hepato-biliary-pancreatic medicine 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
80 years-old >=
Gender Male and Female
Key inclusion criteria 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
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
9) Other unacceptable reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki YAMAGUCHI
Organization Kawasaki Medical School
Division name Department of Clinical Oncology
Zip code
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
Middle name
Last name Yoshiyuki YAMAGUCHI
Organization Kawasaki Medical School
Division name Department of Clinical Oncology
Zip code
Address Matsushima 577, Kurashiki-city, 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 Kawasaki Medical School
Department of Clinical Oncology
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
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
2016 Year 04 Month 07 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
2016 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 17 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
2016 Year 04 Month 07 Day
Last modified on
2017 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025165

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.