Doxorubicin-eluting LC Bead M1 for Patients With Hepatocellular Carcinoma

Inclusion criteria

• The patient has preserved liver function (Child-Pugh A-B class) without significant liver decompensation.
• The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at study entry.
• The patient is age 18 years or older.
• The patient has a life expectancy of > 12 weeks.
• 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).
• 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.
• 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 upper limit of normal (ULN).
• The patient has adequate renal function, as defined by the following criteria:

• Serum creatinine </= 2.0 x the institutional ULN
• The patient has a baseline international normalized ratio (INR) < 1.5.
• The patient, if a woman of childbearing potential, has a negative pregnancy test.
• The patient is able to give written informed consent.
• The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans.
• Patients with early stage HCC may be included in the protocol to receive DEBDOX-M1 prior to resection

Exclusion criteria

• 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).
• The patient is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, targeted therapy, or an investigational agent.
• The patient has extrahepatic, metastatic, symptomatic HCC. Enlarged reactive lymph nodes, or indeterminate lesions, such as lung nodules are acceptable.
• The patient's tumor has replaced >70% of the liver volume.
• The patient has clinically significant ascites. Trace ascites on imaging is acceptable.
• Marco-shunting noted on the hepatic angiogram.
• The patient has untreatable bleeding diathesis.
• The patient has complete main portal vein thrombosis with reversal of flow.
• The patient has a left ventricle ejection fraction of less than 45%.
• The patient has evidence of clinically significant peripheral vascular disease.
• 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
• 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.
• The patient is pregnant or breast-feeding.
• The patient is allergic to contrast media that cannot be readily prevented with premedication or managed.
• The patient has extra-hepatic, metastatic, and symptomatic HCC.