Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using TACE With Antiangiogenesis
Not Applicable
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Procedure: Transcatheter Arterial Chemoembolization
- Registration Number
- NCT00518557
- Lead Sponsor
- Southeast University, China
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Transcatheter Arterial Chemoembolization All patients of this arm are treated by TACE together with Andostatin. 2 Transcatheter Arterial Chemoembolization All patients of this arm are treated by TACE alone: only mixture of Epirubicin and Lipiodol is injected into the feeding arteries of the tumor, without injection of Andostatin.
- Primary Outcome Measures
Name Time Method Safety and tolerability, Mortality 6 months
- Secondary Outcome Measures
Name Time Method Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival 2 years
Trial Locations
- Locations (1)
Department of Interventional Radiology, Zhongda Hospital, Southeast University
🇨🇳Nanjing, Jiangsu, China