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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008082
Receipt No. 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

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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
Email 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
Email panctri@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009517

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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