UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001135 |
|---|---|
| Receipt number | 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 13:53:57 |
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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
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
itoi@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001368
