Hepatocellular carcinoma
Conditions
Sponsors
Kitasato Institute Hospital, Kitasato University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) With pathological confirmation of HCC after the surgery 2) After R(-) resection without tumor residual, and no evidence of recurrence by CT/MRI images 3) Performance status (ECOG) 0, 1, 2 4)Without participations of any other clinical research nor trials. 5)Tolerable cardiovascular disease for the aphaeresis. 6)Patients expected for completion of 7 times administration of DC vaccination 7)Adequate hematologic, hepatic, renal, and cardiac function 8)Negative with HBV, HTLV-1, HIV and so on 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Sever hemorrhagic diathesis 2) Sever psychiatric or mental disorder 3) Severe comorbidity of heart disease (NYHA classIII, IV) 4) Past history of autoimmune disease (PSS, Sjogren syndrome, ITP, MS, RA etc.) 5) During treatment with immunosuppressive agents 6)Suspicious of immunodeficiency or opportunistic infection 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 |
|---|---|
| Two-year recurrence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence free survival rate Grade and efficient of SAE and adverse events Induction antigen-specific immune response | — |
Countries
Japan
Contacts
Public ContactOsamu Takeuchi
Kitasato Institute Hospital Biomedical laboratory
Outcome results
None listed