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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014481
Receipt No. R000016778
Scientific Title The novel therapeutic cancer peptide vaccine therapy for patients with locally advanced or metastatic pacreatic cancer combined with Gemcitabine as the first line therapy.-Phase I/II study-
Date of disclosure of the study information 2014/08/01
Last modified on 2017/04/27

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Basic information
Public title The novel therapeutic cancer peptide vaccine therapy for patients with locally advanced or metastatic pacreatic cancer combined with Gemcitabine as the first line therapy.-Phase I/II study-
Acronym 1408PC
Scientific Title The novel therapeutic cancer peptide vaccine therapy for patients with locally advanced or metastatic pacreatic cancer combined with Gemcitabine as the first line therapy.-Phase I/II study-
Scientific Title:Acronym 1408PC
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The confirmation of the safety and the exploratory evaluation of the efficacy of the novel therapeutic cancer peptide vaccine for patients with locally advanced and metastatic pancreatic cancer combined with Gemcitabine as the first line therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival
Key secondary outcomes

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
Medicine
Interventions/Control_1 novel peptide cocktail vaccine 1mL will be administered by subcutaneous injection on days, 1,8,15 and 22 of each 28-day treatment cycles.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Locally advanced or metastatic pancreatic ductal carcinoma histologically confirmed as adenocarcinoma or squamous cell carcinoma.
2)no prior chemotherapy and radiotherapy
3)KPS score>=80
4)HLA-A*24 or HLA-A*02 must be positive
5)Life Expectancy must be >=3 months
6)Adequate organ functions
7)The written consent form
Key exclusion criteria 1)History of other active malignancy
2)Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding
3)Interstitial pneumonia or pulmonary fibrosis
4)Brain metastasis or symptoms of it
5)Pleural effusion, ascites, and pericardial fluid requiring drainage
6)Active infections
7)Severe nervous disorder or mental disorder
8)Severe organ disorder, equivalent to CTCAE grade3 or greater
9)History of ischemic heart disease, cerebral infarction, or thromboembolism within 12 months
10)Evidence of bleeding diathesis or severe coagulopthy, or patients with those histories
11)Need continuous medication of anticoagulant drug except aspirin
12)Pregnant females or nursing mothers who can not stop lactation after the recruitment
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Yamaue
Organization Wakayama Medical University, School of Medicine
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera Wakayama
TEL 073-441-0613
Email yamaue-h@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoki Miyazawa
Organization Wakayama Medical University, School of Medicine
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera Wakayama
TEL 073-441-0613
Homepage URL
Email mo-0702@wakayama-med.ac.jp

Sponsor
Institute Second Department of Surgery, Wakayama Medical University, School of Medicine
Institute
Department

Funding Source
Organization Second Department of Surgery, Wakayama Medical University, School of 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
2014 Year 08 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 No longer recruiting
Date of protocol fixation
2014 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 08 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
2014 Year 07 Month 04 Day
Last modified on
2017 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016778

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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