UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory trial of a combination therapy of mFolfirinox and immunotherapy against pancreatic cancer.
Title of the study (Brief title)	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	Toshiji Saibara
Organization	Kochi University, School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	Kohasu, Okocho, Nankoku, Kochi 783-8505, Japan
TEL	088-880-2338
Email	vaccine@kochi-u.ac.jp

Public contact
Name of contact person	Keiko Udaka
Organization	School of Medicine, Kochi University
Division name	Anti-tumor Immunotherapy Research Network, Central Office, Department of Immunology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025445