SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

Inclusion criteria

• HCC diagnosis according to the American Association for the Study of Liver Diseases (AASLD) 2010 criteria
• Tumor Stage
• liver only disease
• tumor thrombus at segment is allowed
• no extra hepatic metastases
• tumor encompassing less than 50% of hepatic volume
• previous treatment with Transarterial Chemo Embolization (TACE) - patient must have performed at least 2 sessions of TACE and have signs of viable tumor in CT or MRI performed 30-40 days after last TACE
• presence of measurable lesion (at least one lesion that can be measured equal or more than 1 cm in CT or MRI).
• Maximum lesion size of 10 cm.
• Liver residual volume equal or more than 700cc or 40% of total liver volume
• Child-Pugh A or absence of hepatic cirrhosis
• absence of encephalopathy or ascitis on clinical exam
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Lab exams:
• hemoglobin > or equal 8 mg/dl
• neutrophils > or equal 1.200/mm³
• platelets > or equal 45.000/mm³
• alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 6 times the upper normal limit
• bilirubin equal or < 2 mg/dl
• international normalized ratio (INR) < 1.7
• serum creatinine equal or < 1.5 times the upper normal limit or creatinine clearance > or equal 60 ml/min
• Albumin >2.8 mg/dl
• not being pregnant - a negative pregnancy test is required (for women). Patients in fertile age should use a contraceptive method during treatment and 4 months after.

Exclusion criteria

• Patients with more than 5 discrete lesions in the liver
• Main or common biliary duct invasion
• Patients with main portal vein tumor thrombus or more than 2 portal branch thrombus
• Patients in systemic treatment (sorafenib, chemotherapy). There should be an interval of at least 4 weeks between any medication for treatment of HCC and the current study treatment
• Previous radiation to upper abdomen
• Patients with other malignant neoplasms or previous malignant neoplasms will be accepted in the study if HCC prognosis is worse
• Patients with ischemic myocardial infarction within the last 6 months
• Patients with large esophageal varices with red color sign or bleeding within the last 3 months
• Patients with symptoms of colitis, enteritis, esophagitis, fistula, ileus, necrosis, stenosis or ulcer
• Patients with severe anorexy, constipation, dehydration, diarrhea or vomiting
• Patients unable to understand and sign written informed consent