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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032386
Receipt No. 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 2018/10/26

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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
Email 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
Email shigeo_koido@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine, Kashiwa Hospital, Division of Gastroenterology & Hepatology, Department of Internal Medicine
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 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
2018 Year 04 Month 26 Day
Last modified on
2018 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036935

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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