Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using TACE With Antiangiogenesis

Combination Treatment of TACE With Recombinant Human Endostatin Administrated Via Hepatic Artery in Hepatocellular Carcinoma

The purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of TACE.

Inclusion Criteria:

• Patients with cytologically or histologically documented HCC, who are candidates for TACE
• Child-Pugh Child A or B
• Age >= 18
• Measurable disease by RECIST criteria;
• Performance status ECOG 0-2
• Previous local therapy completed > 4 weeks
• Written informed consent signed
• Normal organ and marrow function defined as:

Haematopoietic:

• WBC ≥ 3,000/µlplatelet count > 80,000/mm3
• haemoglobin > 9g/dL
• Hepatic: Albumin ≥ 2.8 g/dl.serum total bilirubin ≤ 3 mg/dl; AST or ALT < 5 x ULN
• Renal: creatinine < 1.5 x ULN

Exclusion Criteria:

• Metastases
• Prior or concomitant chemotherapy or radiation therapy
• VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
• Severe and/or uncontrolled medical conditions:
• Congestive heart failure, serious cardiac arrhythmia, active coronary artery
• Severe renal impairment
• Patients who anticipate receiving major surgery during the course of the
• Pregnant or breastfeeding patients
• Evidence of bleeding diathesis