TACE+RFA Versus TACE Alone for Intermediate-stage Hepatocellular Carcinoma

Prior treatment

• Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity \> grade 1
• History of abdominal fistula, GI perforation, or intra-abdominal abscess within past 6 months prior to study treatment

Other illness

• Evidence of hepatic discompensation (i.e., refractory ascites, esophageal or gastric variceal bleeding, or hepatic encephalophathy)
• Patients with any other malignancies within the last 3 years before study start
• History of HCC tumor rupture
• Clinically significant (CTC grade 3 or 4) venous or arterial thrombotic disease within past 6 months
• Be allergic to pirarubicin, lobaplatin and iodized oil

Lab values

• Any contraindications for TACE/RFA procedure:
  • I.Impaired clotting test (platelet count \< 60000/mm3, prothrombin activity \< 40%) II.Renal failure / insufficiency requiring hemodialysis or peritoneal dialysis. III.Known severe atheromatosis IV.Known uncontrolled blood hypertension (\> 160/100 mmHg) V.Patients with known active bleeding (e.g. from GI ulcers, esophageal varices) within 2 months prior to baseline/screening visit or with history or evidence of inherited bleeding diathesis or coagulopathy VI.Clinically significant third space fluid accumulation (i.e., ascites requiring tapping despite use of diuretic or pleural effusion that either required tapping or is associated with shortness of breath)

Other

• Pregnant women or lactating women

• Multiple HCC (2-3 lesions), largest lesion 3-7 cm in diameter, or multiple HCC (4-10 lesions), each ≤ 7 cm in diameter
• No vascular invasion or etrahepatic metastases
• Eastern Cooperative Oncology Group Performance Status 0
• Child-Pugh Stage A or B7
• Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to procedure:
  • I.Adequate hematologic function:
• WBC ≥ 4.0 x 109/L (stable, off any growth factor within 4 weeks of study drug administration)
• Neutrophils ≥ 1.5 x 109/L (stable, off any growth factor within 4 weeks of study drug administration)
• Platelets ≥ 60 x 109/L (transfusion to achieve this level is not permitted)
• Hemoglobin ≥ 100 g/L (may be transfused to meet this requirement)
  • II.Adequate hepatic function:
• Serum Aspartate Aminotransferase (AST) ≤ 5×ULN
• Serum Alanine Aminotransferase (ALT) ≤ 5×ULN
• Serum total bilirubin ≤ 51.3 μmol/L
• Serum albumin ≥ 2.8 g/dL
  • III.Adequate coagulation function:
  • a)prothrombin activity ≥ 40%
  • IV.Adequate renal function:
  • a)Serum creatinine \< 110 μmol/L