UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001732
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences Kumamoto University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002079

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.