Clinical study for evaluating immunological efficacy of Glypican-3 peptide vaccine in patients with advanced Hepatocellular carcinoma
Not Applicable
- Conditions
- Hepatocellular Carcinoma (HCC)
- Registration Number
- JPRN-UMIN000005093
- Lead Sponsor
- Section for Cancer Immunotherapy, Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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