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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005677
Receipt No. R000006715
Scientific Title Clinical trial of human homologue of Prp24p-derived peptide vaccine for hepatocellular carcinoma
Date of disclosure of the study information 2011/06/01
Last modified on 2014/11/30

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Basic information
Public title Clinical trial of human homologue of Prp24p-derived peptide vaccine for hepatocellular carcinoma
Acronym A SART3 peptide vaccine for hepatocellular carcinoma
Scientific Title Clinical trial of human homologue of Prp24p-derived peptide vaccine for hepatocellular carcinoma
Scientific Title:Acronym A SART3 peptide vaccine for hepatocellular carcinoma
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safety and efficacy of human homologue of Prp24p-derived peptide vaccine in HCC patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of adverse events and immune responses
Key secondary outcomes

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
Vaccine
Interventions/Control_1 Three times injection of human homologue of Prp24p-derived peptide after HCC local treatments every 2 weeks
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)HCC must be diagnosed
2)Karnofsky Performance Status is equal to or more than 70%
3)Patients must be equal to or more than 20 years old and written informed consent must be obtained
4)WBC is equal to or more than 2,000/mm3
5)Platelet is equal to or more than 50,000/mm3
6)Hb is equal to or more than 8.5 g/dl
7)Level of liver damage must be A or B
8)Serum Cr is equal to or less than 1.5 mg/dl
Key exclusion criteria 1)Severe complications associated with heart, kidney, lung, blood and coagulability
2)Infection of HIV
3)Past medical history of malignancy
4)Surgical treatment, chemotherapy and radiation therrapy within 4 weeks
5)Past medical history of Immunodeficiency, splenectomy and radiation of spleen
6)medical treatments with steroid
7)Patients who are during lactation
8)Patients who are during pregnancy and expected pregnancy
9)Past history of organ transplantation
10)Patients who are predicted a difficulty of following clinical course
11)Patients who are judged inappropriate for clinical trial
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Kaneko
Organization Kanazawa University Hospital
Division name Department of Gastroenterology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2235
Email eishirom@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eishiro Mizukoshi
Organization Kanazawa University Hospital
Division name Department of Gastroenterology
Zip code
Address Kanazawa, Ishikawa
TEL 076-265-2235
Homepage URL
Email eishirom@m-kanazawa.jp

Sponsor
Institute Department of Gastroenterology, Kanazawa University Hospital
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 金沢大学附属病院(石川県)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 01 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
2011 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2011 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
2011 Year 05 Month 31 Day
Last modified on
2014 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006715

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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