UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032386 |
|---|---|
| Receipt number | R000036935 |
| Scientific Title | Treatment with standard chemotherapy and dendritic cells pulsed with WT1 peptides for pancreatic cancer |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2023/04/30 09:18:00 |
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Basic information
Public title
Treatment with standard chemotherapy and dendritic cells pulsed with WT1 peptides for pancreatic cancer
Acronym
Chemotherapy with WT1-DC
Scientific Title
Treatment with standard chemotherapy and dendritic cells pulsed with WT1 peptides for pancreatic cancer
Scientific Title:Acronym
Chemotherapy with WT1-DC
Region
| Japan |
Condition
Condition
unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety and toxicity
Basic objectives2
Others
Basic objectives -Others
the assessment of the immunologic response, tumor response, overall survival (OS), and progression-free survival (PFS) from the first treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety and toxicity
Key secondary outcomes
the assessment of the immunologic response, tumor response, overall survival (OS), and progression-free survival (PFS) from the first treatment
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
| Vaccine |
Interventions/Control_1
standard chemotherapy (GEM/nab-PTX) with WT1 peptides pulsed dendritic cells (WT1-DC)
The WT1-DC vaccine (usually 1 X10^7 cells/dose) was intradermally administered once every 2 or 4 weeks at six different sites (bilateral upper arms, lower abdomen, and femoral regions).
Maximun 15 times injection of The WT1-DC vaccine
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
1) pathologically or cytologically confirmed, measurable, metastatic pancreatic adenocarcinoma or with recurrent disease
2) an HLA type of A*02:01, A*02:06, A*24:02, DRB1*04:05, DRB1*08:03, DRB1*15:01, DRB1*15:02, DPB1*05:01, or DPB1*09:01.3)
3) ages between 20 and 75 years
4) Karnofsky performance status (KPS) of 60% to 100%
5) a minimum 6-month interval from the completion of any previous treatment for recurrent disease
6) a life expectancy of 3 months
7) adequate organ function
etc
Key exclusion criteria
1) pregnancy
2) serious infections
3) severe underlying disease
4) severe allergic disease
5) a judgment of unsuitability by the principal investigator
etc
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeo Koido |
Organization
The Jikei University School of Medicine, Kashiwa Hospital
Division name
Division of Gastroenterology & Hepatology, Department of Internal Medicine
Zip code
Address
163-1, Kashiwa-shita, Kashiwa City, Chiba 277-8567, Japan
TEL
04-7164-1111
shigeo_koido@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Koido |
Organization
The Jikei University School of Medicine, Kashiwa Hospital
Division name
Division of Gastroenterology & Hepatology, Department of Internal Medicine
Zip code
Address
163-1, Kashiwa-shita, Kashiwa City, Chiba 277-8567, Japan
TEL
04-7164-1111
Homepage URL
shigeo_koido@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine, Kashiwa Hospital, Division of Gastroenterology & Hepatology, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine, Kashiwa Hospital, Division of Gastroenterology & Hepatology, Department of Internal Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | 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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 26 | Day |
Last modified on
| 2023 | 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=R000036935
