UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026009 |
|---|---|
| Receipt number | R000025445 |
| Scientific Title | Exploratory trial of a combination therapy of mFolfirinox and immunotherapy against pancreatic cancer. |
| Date of disclosure of the study information | 2017/02/06 |
| Last modified on | 2018/02/07 10:09:35 |
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Basic information
Public title
Exploratory trial of a combination therapy of mFolfirinox and immunotherapy against pancreatic cancer.
Acronym
Exploratory trial of a combination therapy of mFolfirinox and immunotherapy against pancreatic cancer.
Scientific Title
Exploratory trial of a combination therapy of mFolfirinox and immunotherapy against pancreatic cancer.
Scientific Title:Acronym
Exploratory trial of a combination therapy of mFolfirinox 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 Folfirinox chemotherapy. The auxiliary aim is to observe clinical responses and analyze immunological responses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
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 eFOLFIRINOX 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 have experienced local relapse but not metastasis
4) The overexpression of WT1 in the tumor has been observed by immunohistochemical staining.
5) patients bearing HLA-A*24:02 gene
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 or breast-feeding women
10)Patients with severe psychiatric diseases
11)Inappropriate patients for this study judged by the physicians.
Target sample size
1
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
088-880-2338
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
vaccine@kochi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, School of Medicine, Kochi University
Institute
Department
Personal name
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
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
高知大学医学部附属病院（高知）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 06 | 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
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 06 | Day |
Last modified on
| 2018 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025445
