Hepatocellular carcinoma
Conditions
Interventions
Trans-arterial embolization (TAE) with more than 5.0 x 10^6 dendritic cells is performed. Radiofrequency ablation is performed from 3-6 weeks after TAE and DCs.
Sponsors
Juntendo University
Second Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients must be diagnosed as primary hepatocellular carcinoma pathologically or from images. 2) Patients must be inoperable. 3) Patients must have Karnofsky Performance Status above 70. 4) Patients must have one or more tumor of maximum diameter larger than 2.5 cm. The number of tumor must not exceed 5. 6) Patient must be over 20 years old at registration. 7) Patients must weigh over 50 kg. 8) Liver damage or Child-pugh classificaion must be A or B according to latest clinical guideline for primary hepatocellular carcinoma. 9) Bone marrow and kidney function should be adequate at qualification confirmation. 10) Written consent should be obtained for participation to this study. 11) Patient must be capable of outpatient visits.
Exclusion criteria
Exclusion criteria: 1) Patients must not have heart disorder, kidney disorder, respiratory disorder, hematopathy, clotting disorder, or other serious complication. 2) Patients must not be HIV positive. 3) Patients must not have carcinoma nor immunodeficiency in past history. 4) Patients must not have splenectomy nor splen radiation in past history. 5) Patients must not have allo organ transplantation in past history. 6) Patients must not subjected to continuous whole body administration of adrenal cortical steroid or antihistaminic. 7) Patients must have no surgery, chemotherapy nor radiation within 4 weeks before blood collection for treatment in this study. In addition, patients are also excluded if they have not recovered enough from those therapies above. 8) Female patients are excluded from the study when they are pregnant, possibly pregnant, or when they want to be pregnant or they are feeding. 9) Patients must be excluded when expected to be difficult to follow-up. 10) Patients must be excluded when principal investigator judge as inadequate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Safety is assessed at the first blood collection for cell preparation and from TAE to two weeks after RFA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Recurrence-free survival time is evaluated by image diagnosis after RFA. | — |
Countries
Japan
Contacts
Public ContactShuichiro Shiina
Juntendo University Hospital Department of Gastroenterology
Outcome results
None listed