Hepatocellular carcinoma
Conditions
Interventions
Injection of HLA-A24- or -A2-restricted GPC3 peptide (EYILSLEEL or FVGEFFTDV) emulsified with Montanide ISA51 adjuvant. Every 2 weeks, 3 times.
Sponsors
Section for Cancer Immunotherapy, Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Advanced HCC patient satisfying the following conditions, 1)Diagnosed as HCC 2)Age: 20-80 years old 3)ECOG performance status of 0-1 4)HLA-A24 or -A2 positive 5)Child-Pugh A or B 6)Meet the following criteria for organ functions. 1.WBC: more than 3,000/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 AST/ALT: less than 200U/L 6.Serum creatinine: less than 1.5 mg/dL 7)Survival period is expected to be more than 3 months. 8)Written informed consent has been obtained. 9)At least 4 weeks since last therapy for HCC.
Exclusion criteria
Exclusion criteria: 1)Uncontrolled pleural effusion or ascites. 2)Metastatic disease to the brain. 3)There are other malignancies. 4)Active infection excluding HBV, HCV. 5)Positive for HIV. 6)Clinically significant heart disease. (myocardial infarction or unstable angina within the past six months, or uncontrolled cardiac arrhythmias) 7)There are severe complications including cardiac failure, renal failure, liver failure, active gastro-duodenal ulcer, ileus, and uncontrolled Diabetes Mellitus. 8)There is severe psychiatric disorder. 9)Pregnant or lactating woman, who are willing to be pregnant. 10)Past history of severe drug allergy. 11)Immunodeficiency, previous splenectomy, irradiation to the spleen. 12)Ongoing treatment with corticosteroid, or immunosuppressant drugs. 13)Previous allograft transplantation. 14)Responsible doctors judged the patient in appropriate for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Adverse effects of GPC3 vaccination. 2)GPC3-specific immune-responses to GPC3 vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Clinical response rate. 2)Monitoring the level of tumor markers. | — |
Countries
Japan
Contacts
Public ContactTetsuya Nakatsura
Research Center for Innovative Oncology, National Cancer Center Hospital East Section for Cancer Immunotherapy, Investigative Treatment Division
Outcome results
None listed