None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : The AKC is ex vivo-expanded, autologous natural killer cells. AKCs were manufactured from patients’ own lymphocytes under good manufacturing practice (GMP) condit
Sponsors
Bundang CHA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male or female subjects ? 19 years of age •Patients with life expectancy of at least 12 weeks •Confirmed Diagnosis of HCC: - Cirrhotic subjects: Clinical diagnosis by AASLD criteria # HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behaviour for nodules of 1-2cm in diameter # Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria - Documentation of original biopsy for diagnosis is acceptable •Child-Pugh score 1500/mm3 •Platelet count ? 85x10^9/L •Adequate clotting function: INR < 2 •Hepatic: AST and ALT < 5 X ULN •Renal: serum creatinine < 1.5 x ULN •Bilirubin < 2 mg/dL •Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial •The patient must give written, informed consent
Exclusion criteria
Exclusion criteria: Tumor factors • Presence of extrahepatic metastasis • Predominantly infiltrative lesion • Diffuse tumor morphology with extensive lesions involving both lobes. Vascular complications • Hepatic artery thrombosis, or • Partial or complete thrombosis of the main portal vein, or • Tumor invasion of portal branch of contralateral lobe, or • Hepatic vein tumor thrombus, or • Significant arterioportal shunt not amenable to shunt blockage Liver function • Advanced liver disease: ascites, hepatic encephalopathy • Patients with clinically significant gastrointestinal bleeding within the 30 days prior to study entry. Others • Pregnant or lactating women. • Active sepsis or bleeding. • Hypersensitivity to intravenous contrast agents. • The patient has received prior treatment for HCC target lesion. • History of cardiac disease • Hypertension defined as systolic blood pressure greater than 150 mmHg or diastolic pressure greater than 90 mmHg despite optimal medical management. • Therapeutic anticoagulation with coumarin, heparins, or heparinoids. • Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months • Impairment of swallowing that would preclude administration of sorafenib • The patient is, in the opinion of the investigator, unable and / or unwilling to comply with treatment and study instructions • Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted • Any active clinically serious infections (> grade 2 NCI-CTCAE version 3.0) • HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history) • Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results • Known or suspected allergy to the investigational agent or any agent given in association with this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective tumor response, Progression free survival, Immune response | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory test, Radiologic exam, EKG monitoring | — |
Countries
Korea, Republic of
Contacts
Public ContactJooho Lee
Bundang CHA General Hospital
Outcome results
None listed