A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma

Inclusion Criteria:

1. Written Informed Consent
2. ≥18 years of age
3. Diagnosis of HCC
4. Locally advanced HCC
5. Preserved liver function
6. Eastern Cooperative Oncology Group 0 or 1

Exclusion Criteria:

1. Presence of extra-hepatic spread of disease.
2. Macrovascular invasion of lobar portal vein branches or main portal vein.
3. Candidate for surgical resection, transplantation, or local ablation.
4. Prior intra-arterial embolization, chemotherapy or systemic therapy for HCC.
5. Any contraindication for TACE.
6. Platelet count \<50,000/mm3 or international normalized ratio \>1.5.
7. Previous treatment with anthracycline antibiotics (e.g. Doxorubicin) or sorafenib.
8. Unstable coronary artery disease or recent myocardial infarct (i.e. within 1 year).
9. Known ejection fraction \< 50%.
10. Current infections requiring antibiotic therapy.
11. Suffering from a known bleeding disorder.
12. Renal insufficiency (serum creatinine \> 2 mg/dL).
13. Aspartate aminotransferase and/or alanine transaminase \>5 times upper limit of normal.
14. Presence of advanced liver disease.
15. Any contraindication for doxorubicin administration:
16. Any co-morbid condition or social situation, which has a high likelihood of causing poor compliance with the study protocol or jeopardizes the patient's safety.
17. Patient has another primary tumor, with the exception of conventional basal cell carcinoma, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease
18. Participation in a clinical trial of an investigational device or drug within 4 weeks of study entry.
19. Pregnant or breast-feeding patients.