UMIN-CTR Clinical Trial

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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