Chemoembolization Versus Radioembolization in Treating Patients With Liver Cancer That Cannot Be Treated With Radiofrequency Ablation Or Surgery

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Hepatocellular Carcinoma confined to the liver that is unresectable with surgery or unable to be treated with radiofrequency ablation diagnosed by biopsy or imaging criteria (CT/MRI)
• •No segmental, lobar, or main portal vein thrombosis as evidenced by CT or MRI imaging
• •Adults \> 18 years old of either gender
• •Diagnosis of liver confined HCC confirmed by histology or American Association for the Study of Liver Diseases (AASLD) guidelines \[59,60\] \[appendix A\].
• •Lesions \< 1 cm in diameter have a low likelihood of being malignant and should be followed. Lack of growth over 1-2 years suggests it is not HCC.
• •AFP \>200 and radiological evidence (arterial hypervascularity) of lesion \> 2 cm does not require biopsy.
• •Two imaging modalities (triphasic CT, MRI, ultrasound, angiography) demonstrating "arterial hypervascularity" in the background of cirrhosis does not require biopsy
• •One imaging modality with a lesion with arterial hypervascularity with wash out in early or delayed venous phase, does not require a biopsy
• •Atypical appearances on imaging requires a biopsy.
• •Non-conclusive biopsy requires closer monitoring
• •For non-cirrhotics (by biopsy or imaging findings), diagnosis of HCC requires biopsy
• •Patients with \<50% liver involvement
• •Measurable liver confined disease with bi-dimensional measurements, required within 4 weeks of screening. Lesions reported on imaging as "too small to characterize", abdominal lymph nodes \< 2.0 cm or ascites in the setting of cirrhosis are not considered metastatic disease unless cytology proven.
• •No segmental, lobar or main portal vein thrombosis as evidence by cross sectional imaging
• •Prior resection permitted, no prior systemic, ablative or infusion therapy permitted
• •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 \[appendix B\]
• •Childs score of A or B \[appendix C\]
• •Required lab parameters within 28 days of screening
• •Serum bilirubin ≤ 2.0 mg/dl (unless segmental infusion can be performed
• •AST and ALT ≤ 5 times upper limit of normal (ULN)
• •Creatinine ≤ 1.5 times ULN
• •Prothrombin time (PT)/ International normalized ratio (INR) ≤ 2.3 or PT ≤ 6 seconds above control. If subjects are being anticoagulated they can participate if proof of no coagulation abnormality existed prior to use of anticoagulants
• •Negative serum or urine pregnancy test for females of child bearing potential
• •Ability to understand and sign the informed consent; patient must have signed informed consent prior to registration on study
• •Women of childbearing potential and sexually active males must use contraception while on study
• •Lesions must be treatable angiographically by either radioembolization or chemoembolization.