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 significant
liver decompensation.

2. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of
0-2 at 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 with
intrahepatic 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
- Aspartate transaminase (AST) and alanine transaminase (ALT) limit of normal (ULN).

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

- Serum creatinine
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,
and treatment plans.

13. Patients with early stage HCC may be included in the protocol to receive DEBDOX-M1
prior to resection

EXCLUSION CRITERIA:

1. The patient has a history of another primary cancer (ie, a primary cancer not
associated with the patient's current liver tumor), with the exception of (a)
curatively resected nonmelanomatous skin cancer; (b) curatively treated cervical
carcinoma in situ; or (c) other primary solid tumor treated with curative intent, no
known active disease present, and no treatment administered during the last 3 years
prior to enrollment (date of informed consent).

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

3. The patient has extrahepatic, metastatic, symptomatic HCC. Enlarged reactive lymph
nodes, 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 is
acceptable.

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, for
example, 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 Heart
Association classification for heart disease)

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

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

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

- Psychiatric illness/social situations that would compromise patient safety or
limit compliance with study requirements

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

13. The patient is pregnant or breast-feeding.

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

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