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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004641
Receipt No. R000005536
Scientific Title Phase II clinical trial of peptide vaccination with HLA-A2402-restricted KIF20A and VEGFR1 epitope peptides with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer
Date of disclosure of the study information 2010/12/01
Last modified on 2015/06/01

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Basic information
Public title Phase II clinical trial of peptide vaccination with HLA-A2402-restricted KIF20A and VEGFR1 epitope peptides with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer
Acronym Phase II clinical trial of peptide vaccination with chemotherapy in patients with unresectable advanced pancreatic cancer
Scientific Title Phase II clinical trial of peptide vaccination with HLA-A2402-restricted KIF20A and VEGFR1 epitope peptides with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer
Scientific Title:Acronym Phase II clinical trial of peptide vaccination with chemotherapy in patients with unresectable advanced 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 investigate clinical efficacy with Gemicitabine plus peptide vaccine therapy in patients with unresectable advanced pancreatic cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

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 Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Gemcitabine is administered at a dose of 1000 mg/m2 on days 1, 8, and 15 in a 28-day cycle. KIF20A and VEGFR1 peptides are subcutaneously injected weekly at each doses of 2 mg/body in patients with HLA-A*2402-positive group.
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 before undergoing chemotherapy or vaccination.
2. Performance status (ECOG) of the patients are 0-2.
3. more than 20, less than 80 years of age.
4. The presence or absence of measurable or evaluable lesions by RECIST was not taken into account.
5. Patients who have undergone operation, and recovered the influence by surgery. Or two weeks or more have passed since pre-medical treatment.
6. Patients who can expect the survival of three months or more.
7. WBC count more than 3500/mm3, less than 10000/mm3. Plt count more than 100000/mm3. AST and ALT less than 150IU/L. T-Bil less than 2.0mg/dl. Creatinine less than 1.5mg/dl.
8. All patients gave written informed consent.
Key exclusion criteria 1. Patients have uncontrollable associated cancer.
2. Patients have uncontrollable severe infectional diseases.
3. Patients have severe trauma.
4. Patients who are treated with steroid or immunotherapy during clinical trial.
5. Pregnancy or lactation.
6. Patients who have non-recovered injury.
7. Patients judged inappropriated by doctors.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumio Watanabe
Organization Juntendo University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email sumio@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junko Kato
Organization Juntendo University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email jun-kato@juntendo.ac.jp

Sponsor
Institute Department of Gastroenterology Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Juntendo 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
2010 Year 12 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 Completed
Date of protocol fixation
2010 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2010 Year 05 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
2010 Year 12 Month 01 Day
Last modified on
2015 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005536

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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