LC Drug Eluting Bead for Treatment of Liver Cancer Which Cannot be Surgically Removed

* Adults patients (≥ 18 years of age) with a diagnosis of HCC that is not amenable to surgical resection or local ablative therapy
* Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2cm with typical vascular features or AFP \> 200
* Patient must have one lesion \< 8cm or up to five lesions with total diameter \< 8cm
* Quantifiable disease limited to the liver; 40% of liver must be free of tumor burden
* Patient must have at least one tumor lesion that meets both of the following criteria:

  * Lesion can be accurately measured in at least one dimension according to RECIST criteria
  * Lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
* ECOG performance status ≤ 2
* No prior systemic chemotherapy
* At least 4 weeks since prior TACE or interferon
* Not pregnant
* No significant baseline liver dysfunction. Child-Pugh class A and B 7-8 (in abscence of ascites)
* No significant renal impairment (creatinine clearance \< 30mL/minute) or patients on dialysis
* No current infections requiring antibiotic therapy
* Not on anticoagulation or suffering from a known bleeding disorder
* No unstable coronary artery disease or recent MI
* The following laboratory parameters

  * Hemoglobin ≥ 8.5g/dL
  * Total bilirubin ≤ 3.0mg/dL
  * ALT and AST ≤ 5x upper limit of normal
  * Serum creatinine ≤ 1.5x upper limit of normal
  * INR ≤ 1.5 or a PT/PTT within normal limits
  * Platelet count ≥ 50,000/uL
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* HCC with gross vascular invasion or extrahepatic disease
* Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), and any cancer curatively treated \> 3 years prior to entry is permitted
* Renal failure requiring dialysis
* Child-Pugh B9 or C hepatic impairment
* History of cardiac disease: NYHA class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
* Active clinically serious infections (\> CTCAEv3 grade 2)
* Known history of HIV
* Known central nervous system tumors including metastatic brain disease
* History of organ allograft
* Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
* Allergy to the investigational agents or any agent given in association with this trial.
* Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
* Uncontrolled hypertension defined as systolic blood pressure \> 150mmHg or diastolic blood pressure \> 90mmHg
* Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
* Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
* Serious non-healing wound, ulcer, or bone fracture
* Any contraindication for doxorubicin administration:

  * serum bilirubin \> 3mg/dL
  * WBC \< 3000 cells/mm3
  * neutrophil \< 1500 cells/mm3
  * cardiac ejection fraction \< 50 percent assessed by isotopic ventriculography, echocardiography or MRI
  * MUGA scan \< 40% ejection fraction
* Any contraindication for hepatic embolization procedures

Excluded therapies and medications, previous and concomitant:

* Prior use of any systemic anti-cancer chemotherapy for HCC
* Prior use of any systemic investigational agents for HCC
* Major surgery within 6 weeks of start of study drug
* Radiotherapy during study or within 3 weeks prior to start of study drug
* Use of biological response modifiers such as granulocyte colony-stimulating factor (G-CSF)within 3 weeks prio to study entry
* Autologous bone marrow transplant or stem cell rescue within four months of study drug initiation
* Concomitant treatment with rifampin or St. John's wort