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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005093
Receipt No. R000006053
Scientific Title Clinical study for evaluating immunological efficacy of Glypican-3 peptide vaccine in patients with advanced Hepatocellular carcinoma
Date of disclosure of the study information 2011/02/16
Last modified on 2013/05/10

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Basic information
Public title Clinical study for evaluating immunological efficacy of Glypican-3 peptide vaccine in patients with advanced Hepatocellular carcinoma
Acronym Clinical study for evaluating immunological efficacy of GPC3 peptide vaccine in patients with HCC
Scientific Title Clinical study for evaluating immunological efficacy of Glypican-3 peptide vaccine in patients with advanced Hepatocellular carcinoma
Scientific Title:Acronym Clinical study for evaluating immunological efficacy of GPC3 peptide vaccine in patients with HCC
Region
Japan

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

Objectives
Narrative objectives1 We will investigate the GPC3 peptide-specific immune responses induced by GPC3-derived peptide vaccine in both peripheral blood and tumor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes GPC3 peptide-specific immune-responses induced by GPC3 peptide vaccination.
1 Increase of frequency of GPC3-peptide specific CD8 positive T lymphocytes in the blood.
2 Increase of frequency of CD8 positive T lymphocytes into the tumor
Key secondary outcomes Time to Progression : TTP
Disease Control Rate : DCR
Response Rate : RR
Rate of 50% decreasing the level of serum tumor marker
Rate of 50% decreasing the number of Circulating Tumor Cells(CTC)
Adverse effects of GPC3 vaccination.
Overall Survival : OS

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine Maneuver
Interventions/Control_1 Injection of HLA-A24- or -A2-restricted GPC3 peptide (EYILSLEEL or FVGEFFTDV) emulsified with Montanide ISA51 adjuvant.
3 mg intradermally injection, every 2 weeks.
Tumor tissue biopsies after peptide vaccination.
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
85 years-old >
Gender Male and Female
Key inclusion criteria Advanced HCC patient satisfying the following conditions,
1 Diagnosed as HCC
2 Age: 20-85 years old
3 ECOG performance status of 0-1
4 Child-Pugh A or B
5 Meet the following criteria for organ functions.
1. Neutrophil: more than 1,500/mm3
2. Hemoglobin: more than 8.0g/dL
3. Platelet: more than 50,000/mm3
4. Serum bilirubin: less than 3.0 mg/dL
5. Serum albumin: less than 2.8 g/dL
6. Serum AST/ALT: less than 150U/L
7. Serum creatinine: less than 1.5 mg/dL
6 HLA-A*24:02 or HLA-A*02:01, 02:06, 02:07 positive
7 Tumor tissue biopsy is practicable
8 At least 2 weeks since last therapy for HCC.
9 Written informed consent has been obtained.
Key exclusion criteria 1. Uncontrolled pleural effusion or ascites
2. There are other malignancies
3. Active infection excluding HBV, HCV
4. Clinically significant heart disease (myocardial infarction or unstable angina within the past six months, or uncontrolled cardiac arrhythmias)
5. There are severe complications including cardiac failure, renal failure, liver failure, active gastro-duodenal ulcer, ileus, and uncontrolled Diabetes Mellitus
6. There is severe psychiatric disorder
7. Pregnant or lactating woman, who are willing to be pregnant
8. Past history of severe drug allergy
9. Past history of administration of GPC3 peptide vaccination
10. Responsible doctors judged the patient in appropriate for the trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Nakatsura
Organization Research Center for Innovative Oncology, National Cancer Center Hospital East
Division name Section for Cancer Immunotherapy,
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Japan
TEL 04-7131-5490
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Nakatsura
Organization Research Center for Innovative Oncology, National Cancer Center Hospital East
Division name Section for Cancer Immunotherapy,
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Japan
TEL 04-7131-5490
Homepage URL
Email tnakatsu@east.ncc.go.jp

Sponsor
Institute Section for Cancer Immunotherapy,
Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare, 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
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 国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 16 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 01 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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 02 Month 16 Day
Last modified on
2013 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006053

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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