Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma (LDT-RFA)

Inclusion Criteria:

• Age 18 - 75 years, who refused surgery or first recurrence after hepatectomy
• A solitary HCC 3.1-7.0cm in diameter, or 2-3 lesions, sums of diameters ≤ 7.0cm
• Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US
• No extrahepatic metastasis
• No imaging evidence of invasion into the major portal/hepatic vein branches
• No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
• A platelet count of > 40,000/mm3
• No previous treatment of HCC except liver resection

Exclusion Criteria:

• Patient compliance is poor
• Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted

• History of cardiac disease:

  • congestive heart failure > New York Heart Association (NYHA) class 2
  • active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted)
  • cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, *calcium channel blocker or digoxin
  • uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs)
• Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
• Known history of human immunodeficiency virus (HIV) infection
• Known Central Nervous System tumors including metastatic brain disease
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
• Distantly extrahepatic metastasis