Transarterial Chemoembolization with or without Surefire Infusion Device in Treating Patients with Intermediate Stage Liver Cancer that Cannot Be Removed by Surgery

Inclusion Criteria

• Unresectable HCC, defined by imaging criteria or cytohistologic assessment; TACE as a preferred method of treatment is determined by a multidisciplinary Brigham and Women’s Hospital (BWH)/Dana Farber Cancer Institute (DFCI) Liver Tumor Board
• Intermediate stage HCC (Barcelona Clinic Liver Cancer [BCLC] class B), not eligible for curative treatment, but with Child-Pugh A or B; additionally, tumor cannot involve greater than 50% of the entire liver
• Prior systemic chemotherapy is allowable
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Life expectancy of greater than at least 12 months
• White blood cell (WBC) ≥ 3.00 K/uL
• Absolute neutrophil count ≥ 1.5 K/uL
• Platelets ≥ 60 K/uL
• Total bilirubin ≤ 2.0 mg/dl
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional upper limit of normal
• Creatinine ≤ 1.5 mg/dl
• No previous regional treatment (includes surgery, radiation or liver-directed arterial or ablative therapy)
• Main tumor size > 1 cm
• A positive pregnancy test will exclude patients from the study in addition to excluding them from receiving standard therapy
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Participants who have had prior local regional therapy including radiation therapy, transarterial therapy, or ablative therapy
• A hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the non-tumorous liver parenchyma on arterial phase computed tomography scans)
• Participants with known brain metastases should be excluded
• Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy
• Severe underlying cardiac or renal diseases
• Color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Human immunodeficiency virus (HIV)-positive patients are NOT excluded from the study
• Patients who cannot undergo neither MRI nor computed tomography (CT) evaluation/examination
• History of anaphylactic allergic reactions attributed to agents used in study (i.e. doxirubicin, epirubicin, MRI contrast agents or iodinated contrast agents)
• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with chemoembolic agent