UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001732 |
|---|---|
| Receipt number | R000002079 |
| Scientific Title | Cancer vaccination therapy by using tumor-associated antigen GPC3-targeted peptide in the partients who have received trans-arterial infusion chemotherapy against advanced hepatocellular carcinoma -A randomized double blind study- |
| Date of disclosure of the study information | 2009/02/23 |
| Last modified on | 2012/03/23 16:34:03 |
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Basic information
Public title
Cancer vaccination therapy by using tumor-associated antigen GPC3-targeted peptide in the partients who have received trans-arterial infusion chemotherapy against advanced hepatocellular carcinoma -A randomized double blind study-
Acronym
Cancer vaccination therapy in the partients who have received trans-arterial infusion chemotherapy against advanced hepatocellular carcinoma
Scientific Title
Cancer vaccination therapy by using tumor-associated antigen GPC3-targeted peptide in the partients who have received trans-arterial infusion chemotherapy against advanced hepatocellular carcinoma -A randomized double blind study-
Scientific Title:Acronym
Cancer vaccination therapy in the partients who have received trans-arterial infusion chemotherapy against advanced hepatocellular carcinoma
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Confirmination of safety and efficacy about cancer vaccination therapy by using tumor-associated antigen GPC3-targeted peptide in the patients who have received trans-arterial infusion chemotherapy against advanced HCCs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
safety
Key secondary outcomes
immunologicalresponse and clinical efficacy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
Cancer vaccination therapy by using tumor-associated antigen GPC3-targeted peptide in the patients who have received trans-arterial infusion chemotherapy against advanced HCCs.
Interventions/Control_2
Cancer vaccination therapy by using IFA in the patients who have received trans-arterial infusion chemotherapy against advanced HCCs.
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. Patients who have received trans-arterial infusion chemotherapy.
2. more than 20, less than 80 years of age.
3. Performance status (ECOG) of the patients are 0-2.
4. Child-Pugh class A or B.
5. Has adequate organ function as difined by following criteria.
1 WBC count more than 2000/mm3, less than 15000/mm3.
2 Plt count more than 50000/mm3.
3 AST and ALT less than 150IU/L.
4 T-Bil less than 3.0mg/dl.
5 Creatinine less than 3.0mg/dl.
6 Patients who have HLA-A*2402.
7 All patients gave written informed consent.
Key exclusion criteria
1. Patients have uncontrollable associated cancer.
2. Patients have uncontrollable severe infectional diseases.
3. Patients have severe trauma.
4. Patients who are treated with steroid or immunotherapy during clinical trial.
5. Pregnancy or lactation.
6. Patients judged inappropriated by doctors.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Sasaki |
Organization
Graduate School of Medical Sciences Kumamoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Honjo, Kumamoto city, Kumamoto 860-8556, Japan
TEL
096-373-5150
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medical Sciences Kumamoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Honjo, Kumamoto city, Kumamoto 860-8556, Japan
TEL
096-373-5150
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences Kumamoto University
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 02 | Month | 23 | 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
Date of protocol fixation
| 2009 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 23 | Day |
Last modified on
| 2012 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002079
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