Hepatocellular carcinoma
Conditions
Interventions
The patient will take apheresis following serial injection of G-CSF for 4-6 days. After incubation of CD34+ stem cell derived NK cells, the patient will be injected NK cells via peripheral vein. The p
Sponsors
Ohdan Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who underwent initial hepatectomy for HCC 2) Ages between 20 and 79 years old 3) Patients with hemoglobin 10g / dL or more and platelets 100,000 / ul or more 4) Patients who have appropriate vessels for lymphapheresis or who agree with catheter insertion in case of inappropriate vessels 5) Patients who fit into the risk group category of liver cancer recurrence after hepatectomy (AFP 10 ng/ml or more, multiple tumors, one or more of the risk factors for positive pathologic vascular invasion) 6) Patients with Performance Status (PS) 0 or 1 7) Patients with pathologically no tumor residue (R0) 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who have malignant disease except for HCC 2) Patients who have steroids or immunosuppressive drug therapy 3) Patients who have undergone hepatectomy 4) Patients who are not eligible for G-CSF or apheresis Patients with allergy to G-CSF, Pregnant or possibly pregnant, Patients with a history of coronary artery disease or cerebrovascular disease within 6 months, Patients with heart disease (EF<25%), lung disease, renal disease requiring treatment, Patients with neurological disorders, Patients with suspected myeloproliferative disorders such as leukocytosis and thrombocytosis, Patients with leukocytes less than 3,000ul/ml or more than 10,000ul/ml, Patients with or with a history of interstitial pneumonia 5) Patients who have been hospitalized 6 weeks after surgery due to postoperative complications 6) Researchers decide as inappropriate participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation after NK cell immunotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival and recuurrence free survival (1 and 3 years) 2) Effect of immunological response after NK cell immunotherapy 3) Adverse events depending on cell dose | — |
Countries
Japan
Contacts
Public ContactAyaka Morikawa
Hiroshima University
Outcome results
None listed