NCT00518557Unknown不适用
Combination Treatment of TACE With Recombinant Human Endostatin Administrated Via Hepatic Artery in Hepatocellular Carcinoma
Southeast University, China1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety and tolerability, Mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Safety and tolerability, Mortality
时间窗: 6 months
次要结局
- Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival(2 years)
研究者
研究点 (1)
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