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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005345
Receipt No. R000006351
Scientific Title Phase 1 & 2 clinical trial using peptide vaccine for VEGFR1 & 2 in combination with S-1 and Cisplatin for patients with advanced gastric cancer (HLA-A*0201)
Date of disclosure of the study information 2011/03/31
Last modified on 2012/08/13

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Basic information
Public title Phase 1 & 2 clinical trial using peptide vaccine for VEGFR1 & 2 in combination with S-1 and Cisplatin for patients with advanced gastric cancer (HLA-A*0201)
Acronym Clinical trial of VEGFR vaccine with S-1 and Cisplatin (0201)
Scientific Title Phase 1 & 2 clinical trial using peptide vaccine for VEGFR1 & 2 in combination with S-1 and Cisplatin for patients with advanced gastric cancer (HLA-A*0201)
Scientific Title:Acronym Clinical trial of VEGFR vaccine with S-1 and Cisplatin (0201)
Region
Japan

Condition
Condition unresectable or recurrent gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate the safety and cinical effectivity of the VEGFR vaccine restricted to HLA-A*0201 with S-1/CDDP for unresectable or reccurent gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes safety and time to progression
Key secondary outcomes immunological evaluation, anticancer efficacy, accomplishment rate, 1 & 2 years survival rate, median survival time

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
Vaccine
Interventions/Control_1 5weeks/cycle, 2cycles
1mg of VEGFR1 petitide and 1mg of VEGFR2 peptide
inject under the skin week by week.
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
74 years-old >=
Gender Male and Female
Key inclusion criteria The inclusion criteria were as follows
1)gastric cancer
2)unresectable or reccurent gastric cancer
3)paformance status (ECOG) of 0-1
4)with HLA-A*0201
5)major organ function preserved
6)the case should survival for at least 3 months
7)there is at least one estimative lesion
8)over 4week from previously treatment
9)oral intake possible
Key exclusion criteria The exclusion criteria were as follows
1)patients with serious concomitant disease
2)pregnancy
3)lactating
4)hope pregnancy
5)uncontrolled infection
6)cannot stopped steroids or immunosuppressing drug
7)simultaneous or metachronous double cancers
8)unhealed external injury
9)patients with ileus and interstitial lung disease
10)the cases whom the doctors define as inappropriate
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichiro Doki, MD
Organization Osaka University, Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 2-2-E2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3251
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Fuijwara
Organization Osaka University, Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 2-2-E2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3251
Homepage URL
Email

Sponsor
Institute Osaka University, Graduate School of Medicine, Department of Gastroenterological Surgery
Institute
Department

Funding Source
Organization Osaka University, Graduate School of Medicine, Department of Gastroenterological Surgery
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Institute of Medical Science , University of Tokyo
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
2011 Year 03 Month 31 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
2008 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2014 Year 01 Month 01 Day
Date of closure to data entry
2014 Year 01 Month 01 Day
Date trial data considered complete
2014 Year 01 Month 01 Day
Date analysis concluded
2014 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 30 Day
Last modified on
2012 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006351

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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