UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008082 |
|---|---|
| Receipt number | R000009517 |
| Scientific Title | Phase II study of Vaccination with Epitope peptides in combiNation with gemcitabine for UnreSectable Pancreatic Cancer |
| Date of disclosure of the study information | 2012/06/04 |
| Last modified on | 2016/01/05 18:23:03 |
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Basic information
Public title
Phase II study of Vaccination with Epitope peptides in combiNation with gemcitabine for UnreSectable Pancreatic Cancer
Acronym
VENUS-PC study
Scientific Title
Phase II study of Vaccination with Epitope peptides in combiNation with gemcitabine for UnreSectable Pancreatic Cancer
Scientific Title:Acronym
VENUS-PC study
Region
| Japan |
Condition
Condition
Unresectable Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to evaluate the clinical efficacy and safety of OCV-C01 with gemcitabine for advanced Pancreatic Cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1year survival rate
Key secondary outcomes
1)overall survival
2)progression-free survival
3)Response rate
4)disease control rate
5)specific CTL response
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 |
Interventions/Control_1
multicenter HLA-blinded study:
patients will be vaccinated subcutaneously once a week with OCV-C01 and standard 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Invasive ductal carcinoma histologically confirmed of the pancreas.
(2)Life expectancy > 3 months.
(3)Patients must be >=20 years old
(4)ECOG Performance Status must be 0 or 1.
(5)Measureable region evaluable according to the RECIST(ver.1.1)
(6)first line treatment
(7)The following criteria must be satisfied in laboratory tests.
1) Hemoglobin >= 9.0 g/dL
2) White blood cell count >=3,500/mm3 <10,000 lymphocyte >=15%
Neutrophil count >=2,000/mm3
3)Platelet count >=100,000mm3
4)Total bilirubin <=2.0 mg/dL
5)AST <=150 IU/L , ALT <=150 IU/L
6) Serum Creatinine <=1.5 mg/dL
(8)Patients must have signed the consent form.
Key exclusion criteria
(1) Prior treatment of peptide derived from KIF20A, VEGFR-1and VEGFR-2.
(2) Prior immunotherapy for pancreatic cancer
(3) Active double cancer (include asynchronous double cancer with disease-free duration <=1 year) except carcinoma in situ or intramucosal cancer.
(4) Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding.
(5) Interstitial pneumonia or pulmonary fibrosis.
(6) Cerebral metastasis or being suspected.
(7) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage.
(8) Serious infections or being suspected.
(9) Severe nervous disorder or mental disorder.
(10)Uncontrolled heart disease, pulmonary disease, kidney disease, liver disease or another uncontrolled complication.
(11)History of myocardial infarction, severe unstable angina pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months before administration of OCV-C01
(12)Patients who require systemic administration of the following agents during the study treatment period.
1.Corticosteroid
2.Immunosuppresant, Immunostimulant
(13)Current participation in other clinical trials.
(14) patients who received unapproved drugs within two months.
(15)Unhealed traumatic lesion, including traumatic fracture.
(16)Evidence of bleeding diathesis or severe coagulopathy, or patients with those histories
(17)Need continuous medication of antiplatelet drug except aspirin.
(18)patients knows HLA-A type.
(19)Pregnant females or nursing mothers who can not stop lactation after the recruitment.
(20)Pregnant females or nursing mothers who can not stop lactation during the recruitment until 120 days after the last administration.
(21)The subject who was determined by investigator that being not adequate to participate in the trial.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Oka |
Organization
Yamaguchi University Hospital
Division name
Department of Surgery II
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
panctri@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuaki Suzuki |
Organization
Yamaguchi University Hospital
Division name
Department of Surgery II
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
Homepage URL
panctri@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2012 | Year | 06 | Month | 04 | 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
| 2012 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Last modified on
| 2016 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009517
