Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma

Inclusion criteria

• Patients with a confirmed diagnosis of HCC according to the European Association for the Study of the Liver (EASL) criteria for diagnosis, and staged according to the Barcelona clinic liver cancer (BCLC) criteria
• Subject is competent and willing to provide written informed consent in order to participate in the study
• Adults (male or female) patients ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Child Pugh classification is 0-11
• Multidonar or single nodular tumor ≥3-10cm, Patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3-5 weeks. Patient must have at least one tumor lesion that meets the following criteria: Lesion can be accurately measured in at least one dimension according to modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria
• No invasion in the major blood vessel (hepatic portal, hepatic vein) or bile duct by the Magnetic resonance imaging (MRI) or Computed Tomography (CT)
• Proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study
• No current infections requiring antibiotic therapy
• Not actively on cumarin based anticoagulation or suffering from a known bleeding disorder
• Measurable disease per the Response Evaluation Criteria in Solid Tumors (mRECIST)
• Expected survival more than 6 months

Exclusion criteria

• ECOG performance status >2; or Child-Pugh class C11 or more, or ASA class 5
• Bilirubin levels >3 mg/dl
• HCC with large vessel or biliary duct invasion, diffuse HCC or extrahepatic spread
• Patients in which any of the following are contraindicated or present:

• The use of doxorubicin
• MRI
• Hepatic embolization procedures
• White blood cell (WBC) < 3000 cells/mm3
• neutrophil < 1500 cells/mm3
• Cardiac ejection fraction < 50 percent assessed by isotopic ventriculography, echocardiography or MR
• Elevated creatinine greater than or equal to 2.5 mg/dl
• Impaired clotting test (platelet count < 5 x 104/mm3, Prothrombin time-International normalized ratio (PT-INR > 2.0)
• aspartate transaminase (AST) and/or alanine transaminase (ALT) >5x ULN or, when greater >250 U/L
• Known hepatofugal blood flow
• Arterio-venous shunt
• Arterio-portal shunt
• Main stem portal vein occlusion(point 6 in inclusion criteria)
• Women who are pregnant or breast feeding
• Allergy to iodinated contrast used for angiography
• Tumour burden of more than 50% of liver
• Patients with objective signs of active bacterial, viral (human immunodeficiency virus (HIV)), or fungal infection
• Other primary malignancies or evidence of metastatic disease
• Patients previously treated with anthracyclines (other than doxorubicin).
• Any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk that would preclude the safe use of DEB-TACE.
• Under no circumstances should patients be enrolled in this study who is already participating in another study for treatment of primary liver cancer.
• Under no circumstances should patients be enrolled in this study who has received any other embolotherapy (including Selective Internal Radiation Therapy (SIRT)) for the treatment of primary liver cancer.