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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004664
Receipt No. R000005553
Scientific Title Cancer Vaccine Therapy using Gene of antigen related to new cancer origin Epitope Peptide Restricted to HLA-A24 in Patients with Hepatocellular carcinoma(Phase 1/2 study).
Date of disclosure of the study information 2010/12/10
Last modified on 2011/07/04

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Basic information
Public title Cancer Vaccine Therapy using Gene of antigen related to new cancer origin Epitope Peptide Restricted to HLA-A24 in Patients with Hepatocellular carcinoma(Phase 1/2 study).
Acronym Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A24 in Patients with Hepatocellular carcinoma(Phase1/2 study).
Scientific Title Cancer Vaccine Therapy using Gene of antigen related to new cancer origin Epitope Peptide Restricted to HLA-A24 in Patients with Hepatocellular carcinoma(Phase 1/2 study).
Scientific Title:Acronym Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A24 in Patients with Hepatocellular carcinoma(Phase1/2 study).
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate safety and specific immuine responses on cancer vaccination therapy using multi peptides in patient with refractory hepatocellular carcinoma to Standard Therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Evaluation of safety and specific immune response
Key secondary outcomes Progression Free Survival(PFS)
Overall survival(OS)

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 peptide vaccination
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.It is diagnosed as the hepatocellular carcinoma by the case history and the diagnostic imaging. There is no adjustment of The operation, the radio wave cauterizing treatment, the transcatheter arterial embolization therapy,chemotherapy,radiotherapy,and the molecular-targeted therapy .
2.Performance status 0or1
3.The age when registering is from 20 or more to 80 years old or less.
4.There must be change to a morbid lesion that can be the measurement by RECIST.
5.Four weeks or more must pass from the prior treatment.
6.The vital prognosis should be able to be expected for three months or more.
7.WBC >= 1,500 and <=15,000,Platelet >=50,000/mm3 ,Child-PughAorB,Three times or less of keeping kidney function creatinine standard value.
8.Possess HLA-A*2402.
9.Understand the content of treatment, and obtain the person in question's agreement with the document.


Key exclusion criteria 1.The patient who has gullet or gastric varix, with the past of hemorrhage.The one of red color sign (RC2 or more) positivity regardless of the varicosity or F factor of F2 or more. (gullet and stomach varicosity endoscope guideline)
2.The one with pregnant woman, breast-feeding woman, and likelihood of pregnancy and the one in which pregnancy is hoped
3.It has a difficult briskness infectious disease to control.
4.The one with necessity for administering the following medicines while examining it. Whole body administration of adrenal steroid medicine and immunosuppressive agent's whole body administration (As for NSAIDS use is admitted).
5.After the liver transplant
6.It was admitted that the doctor was not suitable.
7.The one to hope for medical treatment to present disease such as Chemotherapy and Molecular-targeted therapy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyotaka Okuno
Organization Kinki University School of Medicine
Division name Department of Surgery
Zip code
Address 377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuyuki Nakata
Organization Kinki University School of Medicine
Division name Department of Surgery
Zip code
Address 377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan
TEL
Homepage URL
Email

Sponsor
Institute Kinki University School of Medicine
Department of Surgery
Institute
Department

Funding Source
Organization Kinki University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Human Genome Center, Institute of Medical Science, The 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 近畿大学医学部付属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 10 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 Enrolling by invitation
Date of protocol fixation
2010 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 12 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 03 Day
Last modified on
2011 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005553

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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