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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027565
Receipt No. R000031604
Scientific Title Exploratory trial of a combination therapy of Gemcitabine, S1 and immunotherapy against pancreatic cancer.
Date of disclosure of the study information 2017/05/31
Last modified on 2017/05/31

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Basic information
Public title Exploratory trial of a combination therapy of Gemcitabine, S1 and immunotherapy against pancreatic cancer.
Acronym Exploratory trial of a combination therapy of Gemcitabine, S1 and immunotherapy against pancreatic cancer.
Scientific Title Exploratory trial of a combination therapy of Gemcitabine, S1 and immunotherapy against pancreatic cancer.
Scientific Title:Acronym Exploratory trial of a combination therapy of Gemcitabine, S1 and immunotherapy against 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 The aim of the study is to examine the safety of a WT1-W10 immunotherapy combined with the standard, modified Gemcitabine chemotherapy. The auxiliary aim is to observe clinical responses and analyze immunological responses.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse events of grade 3 or higher by the CTCAE criteria, Frequency of incidences at respective grade
Key secondary outcomes Frequency of WT1 W10-specific CD8 T cells, DTH (delayed-type hypersensitivity at injection sites), measurement of the tumor size, immunohistochemistry of the tumor (if tumor tissue is obtained)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 A combined chemoimmunotherapy of Gemcitabine and S1 plus WT1-W10 peptide 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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) pancreatic cancer patients diagnosed by pathological examination
2) patients who have been informed about the disease
3) patients who are treated with chemotherapy using Gemcitabine as a single agent
4) The overexpression of WT1 in the tumor has been observed by immunohistochemical staining.
5) patients bearing one or two of HLA-A*24:02, A*02:01, A*02:06, or A*02:07 genes
6) 20 years of age or older, but less than 80 years
7) The performance status should be between 0-2 by the ECOG criteria
8) Function of major organs have been maintained.
Results of the clinical tests are within the following limits.
Neutrophil >= 1,000/ul
Platelets >= 40,000ul
Hemoglobin(Hb) >= 8g /dL
Serum bilirubin =< x3 of upper limit of normal(ULN)
AST and ALT =< x3 of ULN
Serum albumin >= 2.5g/dL
Serum creatinin =< 1.5mg/dL
ECG: no serious irregularities
Sp02 >= 94% (while breathing ambient air)
9) life expectancy > 4 months
10) Patient from whom a written consent is obtained.
Key exclusion criteria 1) Patients with uncontrollable infectious diseases (including active Tuberculosis)
2) patients with severe complications (malignant lypertension, severe congestive heart failure, severe colonary in sufficiency, myocardial, infarction within three months, terminal, stage of liver cirrhousis, uncontrollable diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonitis, etc.)
3) patients with serious comorbidities (generally those of NCI-CTC ver 3.0 grade 3 or higher)
4) patients who have been under parenteral nutrition for more than 24 hours due to impairment of digestive organs.
5) liver metastasis occupying more than 1/3 of the liver
6) Patients with active concomitant malignancy
7) patients with hematopoietic malignancies including MDS, MDS/MPD, CML
8) patients who have received bone marrow or hematopoietic stem cell transplantation
9) pregnant women, breast feeding mothers
10) patients with serious psychological disorders
11) patients whose participation to the study is considered inappropriate by the doctors for various reasons.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiji Saibara
Organization Kochi University, School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan
TEL 088-866-5811
Email vaccine@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Udaka
Organization School of Medicine, Kochi University
Division name Anti-tumor Immunotherapy Research Network, Central Office, Department of Immunology
Zip code
Address Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan
TEL 088-880-2318
Homepage URL
Email vaccine@kochi-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, School of Medicine, Kochi University
Institute
Department

Funding Source
Organization NEC Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 05 Month 31 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
2013 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 14 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
2017 Year 05 Month 31 Day
Last modified on
2017 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031604

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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