UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003514 |
|---|---|
| Receipt number | R000004260 |
| Scientific Title | Clinical trial of AFP-derived peptide vaccine for hepatocellular carcinoma |
| Date of disclosure of the study information | 2010/04/26 |
| Last modified on | 2014/11/30 09:15:57 |
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Basic information
Public title
Clinical trial of AFP-derived peptide vaccine for hepatocellular carcinoma
Acronym
An AFP peptide vaccine for hepatocellular carcinoma
Scientific Title
Clinical trial of AFP-derived peptide vaccine for hepatocellular carcinoma
Scientific Title:Acronym
An AFP 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 AFP peptide vaccine in HCC patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluation of adverse events and immune responses
Key secondary outcomes
Evaluation of anti-tumor effect and tumor marker
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 AFP-derived peptide within 4 weeks after diagnosis of HCC 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)Serum AFP must be positive
3)Karnofsky Performance Status is equal to or more than 70%
4)Patients must be equal to or more than 20 years old and written informed consent must be obtained
5)WBC is equal to or more than 1,500/mm3
6)Platelet is equal to or more than 30,000/mm3
7)Hb is equal to or more than 8.0 g/dl
8)Level of liver damage must be A or B
9)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)Surgical treatment, chemotherapy and radiation therrapy within 4 weeks
4)Past medical history of immunodeficiency, splenectomy and radiation of spleen
5)medical treatments with steroid or anti-histamine
6)Patients who are during lactation
7)Patients who are during pregnancy and expected pregnancy
8)Past history of organ transplantation
9)Patients who are predicted a difficulty of following clinical course
10)Patients who are judged inappropriate for clinical trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Kanazawa University Hospital
Division name
Gastroenterology
Zip code
Address
13-1 Takara-machi, Kanazawa city, Ishikawa
TEL
076-265-2235
eishirom@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eishiro Mizukoshi |
Organization
Kanazawa University Hospital
Division name
Gastroenterology
Zip code
Address
13-1 Takara-machi, Kanazawa city, Ishikawa
TEL
076-265-2235
Homepage URL
eishirom@m-kanazawa.jp
Sponsor or person
Institute
Department of Gastroenterology, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
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
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
| 2010 | Year | 04 | Month | 26 | 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 | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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 | 04 | Month | 20 | Day |
Last modified on
| 2014 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004260
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
