None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Investigational drug treatment arm : CreaVax-HCC + TACE + low dose cyclophosphamide
CreaVax-HCC
-Dosage: 3 x 10^7 cells/injection
-Usage: To induce immune activa
Sponsors
Kyungpook National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must be diagnosed with primary or recurrent hepatocellular carcinoma ineligible for local ablation therapies or surgical resection via one of the following methods 1) Diagnosed as HCC by histology or cytology 2) Diagnosed as HCC based on a typical profile with at least one contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) 2. The following tumor characteristics by contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) 1) There are 4 or more viable intra-hepatic lesions (1 lesion >1 cm diameter), or 2 to 3 viable intra-hepatic lesions (1 lesion >3 cm diameter) 2) The patients who are unable to secure sufficient resection lesion; intra-hepatic lesion >5 cm diameter 3) No evidence of invasion into the major portal or hepatic vein branches 3. Patient has not received local therapy or has received local therapy at least 3 months prior to participate this study 4. Patient who has an inadequate response to curative resection or local ablation 5. Child-Pugh score = 6 points 6. ECOG performance status of 0 or 1 7. Patient must has a life expectancy of at least 6 months. 8. Adequate haematological function Hb >8.5 g/L, WBC = 2,000/mm^3, Absolute neutrophil count >1.5x10^9/L, platelet count = 50 x 10^9 9. Adequate hepatic function Bilirubin = 50 µmol/L, AST or ALT = 5 x ULN /L 10. Adequate renal function: serum creatinine < 1.7 mg/dL 11. Patient is able to provide written informed consent(=19 years of age)
Exclusion criteria
Exclusion criteria: 1. Patient has diffuse type of HCC only. 2. Documented invasion of the main portal vein or extra-hepatic metastasis(including lymph node metastasis) 3. Patient has a history of liver transplantation 4. Patient has ascites or pleural effusion or pericardial fluid not controlled with diuretic therapy. 5. Clinical symptoms of hepatic encephalopathy 6. Patient with immunodeficiency or autoimmune disease that might be aggravated by immunotherapy 7. Patient is currently with Bacterial, viral, fungal, mycobacterial other infectious diseases(excluding chronic infection) or HIV infection 8. Serious concomitant disease (such as bowel paralysis, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes, renal failure, hepatic failure, heart failure, angina pectoris requiring medication or active gastrointestinal ulceration) 9. Medical history of thromboembolism requiring therapy except for the general treatment (pulmonary thromboembolism or cerebral infarction) within 12 months, or any paralysis due to thromboembolism before clinical enrollment 10. History of documented congestive heart failure, angina pectoris requiring medication, evidence of transmural myocardial infarction on electrocardiogram (ECG), clinically significant valvular heart disease, or an uncontrollable arrhythmia 11. Known anaphylactic hypersensitivity to iodinated contrast medium 12. Pregnant woman, nursing woman or woman is going to be pregnant within 6 months 13. Treatment with any investigational agent within 12 weeks of screening 14. Psychiatric disorder that may interfere with consent or protocol compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate;Complete response rate - STUDY2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate(STUDY1) and Complete response rate(STUDY2);Overall survival;TACE treatment times;Disease control rate;Progression free survival;Time to appearance of extra-hepatic spread or vascular invasion;Change in tumor marker(AFP and PIVKA II) concentration;Child-Pugh Score change;Immune response;Safety profile | — |
Countries
Korea, Republic of
Contacts
Public ContactMi Joo Lee
Kyungpook National University Hospital
Outcome results
None listed