Retrospective Analysis of Patients Treated With Bevacizumab in GHPSJ Intraperitoneal for the Treatment of Refractory Malignant Ascites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of the ascites volume
研究概览
简要总结
The refractory malignant ascites is a complication of advanced stages of many cancer types. It is characterized clinically by abdominal pressure sensation, shortness of breath and pelvic pain. Thus, it contributes to decreased quality of life for these patients in palliative care.
Conventional treatment is based on paracentesis of ascites. The progression of the disease leads to increased production of ascites requiring more frequent paracentesis. Main therapeutic alternatives are constituted by the controversial use of diuretics and the use of an antibody inhibiting the activity of the Vascular Endothelial Growth Factor (VEGF): bevacizumab. Catumaxomab, a monoclonal antibody anti-EpCAM and CD3, developed for the treatment of refractory malignant ascites showed no sufficient clinical benefit.
VEGF is overexpressed in many tumors. VEGF causes an increase in capillary permeability and capillary filtration surface generating increased protein extravasation. These phenomena are responsible for an increase of the volume of ascites product. Thus the use of inhibitors of VEGF, such as bevacizumab, could reduce the production of ascites.
The efficacy of bevacizumab to decrease the volume of ascites product was demonstrated on small animals in intraperitoneal administration.
Studies in humans are few and the doses used are not consistent from one study to another.
详细描述
Main objective / secondary:
The objective of this study is to describe the population, adverse effects, the volume of ascites product and time between paracentesis in patients receiving bevacizumab in intraperitoneal through a refractory malignant ascites.
Methodology :
This is a retrospective study mono centric and non-interventional. data collected
- Name,
- date of birth,
- dates and numbers injection of bevacizumab doses
- side effects,
- type of cancer, TNM classification,
- ascites volume collected during paracentesis prior to the introduction of IP bevacizumab,
- frequency of paracentesis before the introduction of IP bevacizumab,
- ascites volume collected during paracentesis after the introduction of IP bevacizumab,
- frequency after paracentesis after the introduction of IP bevacizumab,
- albumin
- Number of lines of chemotherapy received
- Treatment monotherapy or in combination with other chemotherapies
- WHO Stadium in each course
- Date of death
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All assigns patients received at least one injection of bevacizumab intraperitoneal within GHPSJ between 01/01/2007 and 31/12/2014
排除标准
- •No exclusion criteria
结局指标
主要结局
Assessment of the ascites volume
时间窗: 1 Hour before introduction of bevacizumab
Assessment of the ascites volume (mL) collected during paracentesis prior to the introduction of IP bevacizumab
次要结局
- Assessment of the TNM classification of the cancer(Day1)
- Assessment of the number of paracentis happened(Month 12)