UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005345 |
|---|---|
| Receipt number | 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 19:47:09 |
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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
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
Sponsor or person
Institute
Osaka University, Graduate School of Medicine, Department of Gastroenterological Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006351
