NCT01838538Unknown2 期
Clinical Study in Treatment of Malignant Ascites of Ovarian Cancer With Intraperitoneal Injection Bevacizumab Combined With Intraperitoneal Hyperthermic Perfusion Chemotherapy
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
To study the efficacy and safety of intraperitoneal injection bevacizumab combined with intraperitoneal hyperthermic perfusion chemotherapy in treatment of malignant ascites of ovarian cancer. To analyze the clinical significance of the concentration change of vascular endothelial growth factor (VEGF) in ascites in treatment of intraperitoneal injection bevacizumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
- •Histologically confirmed and documented ovarian cancer with malignant ascites.
- •ECOG(Eastern Cooperative Oncology Group, ECOG) PS 0-
- •Life expectancy of >3 months.
- •No serious inadequate bone marrow function, liver and renal function or significant cardiovascular disease.
排除标准
- •Known hypersensitivity to any of the study drugs or excipients.
- •Any current anti-cancer therapy.
- •No evidence of ascites.
- •Key organ dysfunction.
- •Significant cardiovascular disease (e.g. congestive heart failure (CHF), uncontrolled cardiac arrhythmia, angina, heart valve disease, myocardial infarction and refractory hypertension need to be long time controlled by medicine).
- •Non-healing wound, ulcer or bone fracture.
- •Uncontrolled psychiatric history.
研究组 & 干预措施
Bevacizumab+TC
Experimental
The treatment group were accepted intraperitoneal injection with bevacizumab (avastin) 300mg after each intraperitoneal hyperthermic perfusion chemotherapy for 6 weeks.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
objective response rate
时间窗: 24month
次要结局
未报告次要终点
研究者
DuNan
Chief Physician
Chinese PLA General Hospital
研究点 (1)
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