Doxorubicin-eluting LC Bead M1 for Patients With Hepatocellular Carcinoma

INCLUSION CRITERIA:

1. The patient has preserved liver function (Child-Pugh A-B class) without significantliver decompensation.

2. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2at study entry.

3. The patient is age 18 years or older.

4. The patient has a life expectancy of > 12 weeks.

5. The patient has measurable or evaluable disease that will be directly treated withintrahepatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).

6. The patient has adequate hematologic function as defined by the following criteria:

• An absolute neutrophil count (ANC) ≥ 1500/micro L,

• Hemoglobin ≥ 9.5 g/dL, and a

• Platelet count ≥ 50,000/micro L.

7. The patient has adequate hepatic function, as defined by the following criteria:

• Total bilirubin </= 3.0 mg/dL

• Aspartate transaminase (AST) and alanine transaminase (ALT) </= 8 x the upperlimit of normal (ULN).

8. The patient has adequate renal function, as defined by the following criteria:

• Serum creatinine </= 2.0 x the institutional ULN

9. The patient has a baseline international normalized ratio (INR) < 1.5.

10. The patient, if a woman of childbearing potential, has a negative pregnancy test.

11. The patient is able to give written informed consent.

12. The patient is willing and able to comply with study procedures, scheduled visits, andtreatment plans.

13. Patients with early stage HCC may be included in the protocol to receive DEBDOX-M1prior to resection

EXCLUSION CRITERIA:

1. The patient has a history of another primary cancer (ie, a primary cancer notassociated with the patient's current liver tumor), with the exception of (a)curatively resected nonmelanomatous skin cancer; (b) curatively treated cervicalcarcinoma in situ; or (c) other primary solid tumor treated with curative intent, noknown active disease present, and no treatment administered during the last 3 yearsprior to enrollment (date of informed consent).

2. The patient is receiving concurrent treatment with other anticancer therapy, includingother chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization,targeted therapy, or an investigational agent.

3. The patient has extrahepatic, metastatic, symptomatic HCC. Enlarged reactive lymphnodes, or indeterminate lesions, such as lung nodules are acceptable.

4. The patient's tumor has replaced >70% of the liver volume.

5. The patient has clinically significant ascites. Trace ascites on imaging isacceptable.

6. Marco-shunting noted on the hepatic angiogram.

7. The patient has untreatable bleeding diathesis.

8. The patient has complete main portal vein thrombosis with reversal of flow.

9. The patient has a left ventricle ejection fraction of less than 45%.

10. The patient has evidence of clinically significant peripheral vascular disease.

11. The patient has clinically significant or symptomatic extrahepatic disease, forexample, an uncontrolled inter-current illness including, but not limited to:

• Ongoing or active infection requiring parenteral antibiotics

• Symptomatic congestive heart failure (class II to IV of the New York HeartAssociation classification for heart disease)

• Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months

• Uncontrolled hypertension (systolic blood pressure > 150 mmHg, diastolic bloodpressure > 90 mmHg, found on 2 consecutive measurements separated by a 1-weekperiod despite adequate medical support)

• Clinically significant cardiac arrhythmia (multifocal premature ventricularcontractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic orrequires treatment [NCI-CTCAE Grade 3] or asymptomatic sustained ventriculartachycardia)

• Psychiatric illness/social situations that would compromise patient safety orlimit compliance with study requirements

12. There is evidence of substance abuse or medical, psychological or social conditionsthat may interfere with the patient's participation in the study or evaluation ofstudy results.

13. The patient is pregnant or breast-feeding.

14. The patient is allergic to contrast media that cannot be readily prevented withpremedication or managed.

15. The patient has extra-hepatic, metastatic, and symptomatic HCC.