None listed
Conditions
Interventions
Biological/Vaccine : Dosage: 50 million cells/injection
Duration: 4 times every two weeks/2 times every four weeks/total 6 times injections
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Radiologically(CT, MRI, etc.) confirmed(TNM stage I ~ IIIC) primary hepatocellular carcinoma removed through surgical and/or non-surgical(PEI, RFA, TACE) treatment 2) Adults (Men or women) aged between 20 and 80 years 3) Patient is healthy by getting an Eastern Co-operative Oncology Group (ECOG) performances status of 0, 1 or 2 4) Patient must have a life expectancy of at least 3 months 5) Hematological function: Hemoglobin = 8.5g/dL, WBC = 2,000/mm3, Platelet = 50,000/mm3 6) Liver function: Child-Pugh class A or B 7) Adequate renal function: Creatinine < 1.5mg/dL 8) Patients represent DTH positive about recall antigen, PPD exposed in the past 9) Patients who did not receive organ allografts, not underwent immunotherapy, hormonal therapy or chemotherapy within the last 30 days and patients recovered from its side effects 10) Patients who have voluntarily signed written consent forms
Exclusion criteria
Exclusion criteria: 1) Patients with other cancer or the history of cancer within the last 5 years 2) Patients with other organ metastasis except regional lymph nodes metastases 3) Patients with the medical history of autoimmune disease or with immunodeficiency or autoimmune disease that might be aggravated by immunotherapy 4) Patients not exceeding two weeks after antibiotic treatment needed due to a serious infectious disease. 5) HIV positive patients 6) Patients with cardiopulmonary disability judged by the investigator 7) Patients with the medical history of psychological disease or epilepsy 8) Patients who has participated in another clinical trial within the last 4 weeks of the start of study 9) Patients administered immunosuppressive drug like cyclosporin A, Azathioprine within the last 3 months of the start of study 10) A pregnant woman, breast-feeding woman or woman who wants to be pregnant during the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Cancer antigen specific celluous immune response induction | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical confirmed recurrence rate;Time to Progression;Overall Survival;concentration change of immunosuppressive agent;Concetration change of AFP & PIVKAII in blood ;Karnofsky performance status scale | — |
Countries
Korea, Republic of
Contacts
Public ContactYoon Jun Kim
Seoul National University Hospital
Outcome results
None listed