Efficacy of Radiation Therapy and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma (HCC) (RTANDTACE)

Inclusion Criteria:

• 18 and older than 18 years, and less than 70 years
• Histologically diagnosed HCC, or clinically diagnosed HCC based on the American Association of Study of Liver Disease (AASLD) noninvasive diagnostic criteria for HCC larger than 2 cm in diameter (Patients with chronic HBV or HCV infection, and/or evidence of liver cirrhosis, and typical enhancement pattern (arterial enhancement and portal or delayed washout) on dynamic computed tomography (CT) or magnetic resonance imaging (MRI), or mass with serum alpha fetoprotein level more than 200 ng/mL)
• Treatment naïve HCC patients or patients who received a locoregional therapy(-ies) (radiofrequency ablation, percutaneous ethanol injection, surgical resection; TACE is not allowed) to nontarget lesion at least 3 months prior to baseline scan
• HCC invasion to 1st or 2nd order branch of portal vein
• HCC greater than 2 cm and the tumor volume should be less than half of total liver volume
• CTP score 6 or less than 6 (Child A class only)
• ECOG performance status 0 or 1
• Women with childbearing potential and men must agree to use adequate contraception prior to study entry and during study participation
• Patients who refuse to use sorafenib
• The patient must give written, informed consent

Exclusion Criteria:

• Age of 70 and older, or younger than 18
• HCC less than 2 cm, or tumor volume larger than half of total liver volume
• Invasion to both right and left portal veins, or main portal vein
• Invasion to hepatic vein or inferior vena cava
• Presence of extrahepatic metastasis
• Recurred HCC after liver transplantation
• Prior history of any treatment to target lesion
• Any history of previous RT, TACE, sorafenib or other systemic therapy
• Prior locoregional therapy (radiofrequency ablation, percutaneous ethanol injection therapy, surgery) within 3 months before baseline scan
• CTP score more than 6 (Child class B or C)
• ECOG performance status more than 1
• Presence of ascites or encephalopathy
• Absolute neutrophil count less than 1,000/mm3
• Platelet count less than 60,000/mm3
• INR of prothrombin time more than 1.5
• Serum creatinine more than 1.5 mg/dL
• AST or ALT more than 5x upper limit normal(ULN)(200 IU/L)
• Bilirubin more than 3 mg/dL
• Recent gastrointestinal bleeding including variceal bleeding within 3 months
• History of active gastro-duodenal ulcers within the past 6 months. However, the patient is eligible if a more recent gastroscopy shows complete healing of ulcers.
• Major surgery or serious non-healing wounds within 3 months of start of RT
• Pregnancy or breastfeeding. All female patients with childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
• Previous or concurrent cancer that is distinct in primary site or histology from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis and T1) (Any cancer curatively treated at least 3 years prior to entry is permitted).
• Any active clinically serious infections (Grade 3, CTCAE version 4.0)
• History of human immunodeficiency virus (HIV) infection
• History of organ allograft
• Patients who agree to use sorafenib