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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003773
Receipt No. R000004571
Scientific Title Phase I study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy.
Date of disclosure of the study information 2010/06/21
Last modified on 2014/07/10

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Basic information
Public title Phase I study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy.

Acronym Peptid vaccination to prevent recurrence of HCV-positive liver cancer.

Scientific Title Phase I study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy.

Scientific Title:Acronym Peptid vaccination to prevent recurrence of HCV-positive liver cancer.

Region
Japan

Condition
Condition liver cancer

Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The Object of the study is to investigate safety of peptide-cocktail vaccines consist of 10 cancer-derived peptides and 3 HCV-derived peptides emulsified with incomplete Freund's adjuvant.

Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Safety, to evaluate with CTCAE v4.0

Key secondary outcomes Immunological responses (anti-peptide IgG)


Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 <Treatment with 6 times, every weeks>
Interview : Day1, 8, 15, 22, 29, 36
Treatment : Day1, 8, 15, 22, 29, 36
Watching adverse events : Day1, 8, 15, 22, 29, 36
Immune function test : Day36
Blood test : Day36
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 The subjects must satisfy the following conditions.
1)HCV-positive patients with liver cancer who have undergone radical therapy and no legion has been confirmed by ultrasonography and/or CT.
2) Patients must be at a score level
0~1 of performance status (PS) (ECOG).
3) Patients must satisfy the followings:
WBC is more than 2,200/mm3
Lymphocyte is more than 1,000/mm3
Hb is more than 8.0g/dL
Platelet is more than 50,000/mm3
Serum Creatinine is less than 2.0mg/dL
Total Bilirubin is less than 2.5mg/dL
4) Patients must be at a total score level 7 or less of Child-Pugh
5) Patients must be more 20 year-old or more to 80 years old or less.
6)Patients must be expected to survive more than 3 months.
7) Written informed consent must be obtained from patients.
Key exclusion criteria The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2)Patients with multiple active cancers
3)Patients suspected with immunodeficiency and opportunistic infection.
4) Patients with the past history of severe allergic reactions.
5)Patients who are during pregnancy, lactation expectant, and desiring future fertility.
6)Patients with a score II or more of hepatic encephalopathy.
7) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Yutani
Organization Kurume University

Division name Cancer Vaccine Center
Zip code
Address Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL 0942-27-5210
Email yutani@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamada
Organization Kurume University
Division name Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Zip code
Address Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL 0942-31-7572
Homepage URL
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Cancer Vaccine Center
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science, and Technology, Japan

Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2010 Year 06 Month 21 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
2010 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2010 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
2010 Year 06 Month 17 Day
Last modified on
2014 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004571

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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