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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001135
Receipt No. R000001368
Scientific Title Clinical study of immunotherapy for unresectable advanced pancreatic cancer.
Date of disclosure of the study information 2008/04/25
Last modified on 2013/04/30

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Basic information
Public title Clinical study of immunotherapy for unresectable advanced pancreatic cancer.
Acronym Clinical study of immunotherapy for unresectable advanced pancreatic cancer.
Scientific Title Clinical study of immunotherapy for unresectable advanced pancreatic cancer.
Scientific Title:Acronym Clinical study of immunotherapy for unresectable advanced pancreatic cancer.
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safty and efficacy of the intratumoral DC injection with Gemcitabine therapy for unresectable pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Clinical responses/Safety
Key secondary outcomes immune response

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 Vaccine Maneuver
Interventions/Control_1 Intratumoral dendritic cells injection
Chemotherapy: Gemcitabine(1000mg/m2)
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Histologically or cytologically proven unresectable advanced pancreatic cancer.
At least one measurable lesion.
Age: 20-75 years old.
Performance status 0-2.
No serious abnormality in bone marrow, liver and/or renal functions.
Key exclusion criteria patients who have: uncontrolled infections; active autoimmune diseases; serious cardiac disease, and who have received continuous systemic steroids.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Moriyasu Fuminori
Organization Tokyo Medical University Hospital
Division name Department of Hepatology and Gastroenterology
Zip code
Address 6-7-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-3342-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Itoi Takao
Organization Tokyo Medical University Hospital
Division name Department of Hepatology and Gastroenterology
Zip code
Address 6-7-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-3342-6111
Homepage URL http://www.tokyo-med.ac.jp/int4/info/index7-3.htm
Email itoi@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization Tokyo Medical University Hospital
Graduate School of Medicine, The University of Tokyo
Seta Clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Graduate School of Medicine, The University of Tokyo
Seta Clinic
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 東京医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2008 Year 04 Month 25 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
no significant different
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 Completed
Date of protocol fixation
2007 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
2013 Year 04 Month 30 Day
Date trial data considered complete
2013 Year 04 Month 30 Day
Date analysis concluded
2013 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2008 Year 04 Month 25 Day
Last modified on
2013 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001368

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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