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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009881
Receipt No. R000011579
Scientific Title Phase I clinical trial of HLA-A*2402 restricted epitope peptide cocktail therapy with S-1 for patients with unresectable advanced metastatic pancreatic cancer.
Date of disclosure of the study information 2013/01/28
Last modified on 2013/01/28

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Basic information
Public title Phase I clinical trial of HLA-A*2402 restricted epitope peptide cocktail therapy with S-1 for patients with unresectable advanced metastatic pancreatic cancer.
Acronym Phase I clinical trial of HLA-A*2402 restricted epitope peptide cocktail therapy with S-1 for patients with unresectable advanced metastatic pancreatic cancer.
Scientific Title Phase I clinical trial of HLA-A*2402 restricted epitope peptide cocktail therapy with S-1 for patients with unresectable advanced metastatic pancreatic cancer.
Scientific Title:Acronym Phase I clinical trial of HLA-A*2402 restricted epitope peptide cocktail therapy with S-1 for patients with unresectable advanced metastatic 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 this study is to examine the safety of epitope peptide from
VEGFR1, 2, KIF20A restricted to HLA-A*2402 with S-1 chemotherapy in patients with unresectable advanced pancreatic cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Safety
Key secondary outcomes Immunological response, Time to progression, Overall survival

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 vaccination using 3 epitope peptides restricted to HLA-A*2402 with S-1 chemotherapy
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)Patients who have unresectable advanced pancreatic cancer
2)The presence or absence of measurable or evaluable lesions by RECIST was not taken into account.
3)Performance status (ECOG) of the patients are 0-2.
4)more than 20, less than 80 years of age.
5)Patients who can expect the survival of three months or more.
6)Patients who have undergone operation, and recovered the influence by surgery. Or two weeks or more have passed since pre-medical treatment.
7)Patients who have not been treated with S-1.
8)Adequate food intake
9)without dysfunction of multiple major organs
10)with HLA-A*2402
11)All patients gave written informed consent.
Key exclusion criteria 1)Pregnancy or lactation
2)Patients with the intention of pregnancy.
3)Patients have uncontrollable severe infectional diseases.
4)severe diarrhea.
5)Patients who are treated with steroid or immunotherapy during clinical trial.
6)Patients have uncontrollable multiple cancer.
7)Patients who have non-recovered injury.
8)Patients who have ileus and interstitial lung disiease.
9)Patients whom doctors define as inappropriate.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhisa Shinomura
Organization Sapporo Medical University
Division name 1st Department of Internal Medicene
Zip code
Address Nishi 16, Minami 1, Chuoku, Sapporo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masayo Hosokawa
Organization Sapporo Medical University
Division name 1st Department of Internal Medicene
Zip code
Address
TEL 011-611-2111
Homepage URL
Email hmasayo@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

Funding Source
Organization Sapporo Medical University, 1st Department of Internal Medicine
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 01 Month 28 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 No longer recruiting
Date of protocol fixation
2010 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 10 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
2013 Year 01 Month 28 Day
Last modified on
2013 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011579

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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