Hepatocellular carcinoma
Conditions
Sponsors
Kitasato Institute Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnostic imaging of HCC that can be evaluated by RECIST 2) Refractory HCC for standard therapies or recurrence HCC after hepatectomy with chemotherapy and/or radiation therapy resistance 3) Performance status (ECOG) 0, 1, 2 4) Patients expected for completion of 7 times administration of DC vaccination 5) Adequate hematologic, hepatic, renal, and cardiac function WBC >= 1,500/mm3 Absolute lymphocyte count >= 500/mm3 Hemoglobin >= 8.0g/dL Total bilirubin <= 2.0mg/dL Creatinine <= 2.0 mg/dL Platelet >= 50,000/mm3 AST and ALT within 5 times of reference value 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Sever hemorrhagic diathesis PT <50% APTT >60% Doctors judgment of severe bleeding tendency 2) Carrier of HBV, HTLV-1, HIV and so on 3) Severe comorbidity of heart disease (NYHA classIII, IV) 4) Intolerable cardiovascular disease for the apheresis 5) Past history of autoimmune disease (PSS, Sjogren syndrome, ITP, MS, RA etc.) 6) During treatment with immunosuppressive agents 7) Severe allergy with penicillin or picibanil 8) Pantients with adverse events of CTCAE v4.0 >= grade 3 of nonhematological toxicity, or >= grade 4 of hematological toxicity 9) Pregnancy, nursing women 10) Male hope to impregnate 11) Patients whom doctors judged inadequate to the enrollment of this study by other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Countries
Japan
Contacts
Public ContactOsamu Takeuchi
Kitasato Institute Hospital Biomedical laboratory
Outcome results
None listed