UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002614
Receipt No. R000003190
Scientific Title A Phase II study of Glypican-3(GPC3) peptide vaccine as adjuvant treatment for Hepatocellular carcinoma(HCC) after Surgical resection or Radiofrequency ablation(RFA)
Date of disclosure of the study information 2009/10/11
Last modified on 2014/10/14

* 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 A Phase II study of Glypican-3(GPC3) peptide vaccine as adjuvant treatment for Hepatocellular carcinoma(HCC) after Surgical resection or Radiofrequency ablation(RFA)
Acronym A Phase II study of GPC3 peptide vaccine as adjuvant treatment in the prevention of recurrence of HCC
Scientific Title A Phase II study of Glypican-3(GPC3) peptide vaccine as adjuvant treatment for Hepatocellular carcinoma(HCC) after Surgical resection or Radiofrequency ablation(RFA)
Scientific Title:Acronym A Phase II study of GPC3 peptide vaccine as adjuvant treatment in the prevention of recurrence of HCC
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 efficacy and safety of GPC3 peptide vaccine in the adjuvant treatment of HCC after potentially curative surgical resection or RFA
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The one-year and two-year recurrence rate
Key secondary outcomes Adverse effects of GPC3 vaccination.
GPC3-specific immune-responses to GPC3 vaccination.

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 Injection of HLA-A24- or -A2-restricted GPC3 peptide (EYILSLEEL or FVGEFFTDV)
Emulsified with Montanide ISA51 adjuvant.
3 mg intradermally injection, every 2 weeks, 6 times, and every 2 months, 4 times, total 10 times in a year, until disease recurrence
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 1. Diagnosed as initial HCC
2. Subjects who undergone potentially curative surgical resection or RFA for treatment of HCC
3. 4 to 6 weeks from resection or RFA, to CT/MRI scan date. Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility CT/MRI scan.
4. Age: 20-85 years old
5. ECOG performance status of 0-2
6. Child-Pugh A or B
7. Meet the following criteria for organ functions.
Serum bilirubin:less than 3.0 mg/dL
Serum AST/ALT:less than 200U/L
Serum creatinine:less than 1.5 mg/dL
8. Written informed consent has been obtained.
9. HLA-A24 or -A2 positive


Key exclusion criteria 1. Evident invasion to the portal vein, hepatic vein, or bile duct
2. Uncontrolled pleural effusion or ascites
3. There are other malignancies
4. Active infection excluding HBV, HCV
5. Clinically significant heart disease (myocardial infarction or unstable angina within the past six months, or uncontrolled cardiac arrhythmias)
6. There are severe complications including cardiac failure, renal failure, liver failure, active gastro-duodenal ulcer, ileus, and uncontrolled Diabetes Mellitus
7. There is severe psychiatric disorder
8. Pregnant or lactating woman, who are willing to be pregnant
9. Past history of severe drug allergy
10. Responsible doctors judged the patient in appropriate for the trial
Target sample size 40

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 Division of Cancer Immunotherapy,
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Japan
TEL 04-7131-5490
Email tnakatsu@east.ncc.go.jp

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 Division of 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 Division of 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 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

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 11 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
2009 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2014 Year 10 Month 10 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 10 Month 11 Day
Last modified on
2014 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003190

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.