Intrapleural Bevacizumab Injection for Treating Malignant Pleural or Pericardial Effusion in Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Lung cancer symptom
研究概览
简要总结
Malignant pleural or pericardial effusion is common in lung cancer, and intrapleural drugs injection is important in the treatment. Non- cytotoxic drugs include those with a sclerosing effect that produces pleurodesis, which is easy to cause severe chest pain despite of no influence on the following chemotherapy. Tumor angiogenesis is important in producing MPE. Bevacizumab has been administrated locally in treating optic nerve sickness successfully by anti-VEGF mechanism. So we hypothesize that intrapleural bevacizumab is also effective in treating MPE.
详细描述
Inclusion Criteria:
- Histological or cytological diagnosis of non-small cell lung cancer.
- Cytological diagnosis of malignant pleural or pericardial effusion (MPE)
- Symptomatic MPE evaluated by researchers
- Unsuitable for or reject systemic therapy of tumor
- Continuous TKI treatment after TKI-resistance
- Estimated survival of more than 3 months. 7.18 years or older
Exclusion Criteria:
- Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants
- Be allergic to bevacizumab
- Pregnant or lactating woman
- Pleural or pericardial infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of non-small cell lung cancer.
- •Cytological diagnosis of malignant pleural or pericardial effusion (MPE)
- •Symptomatic MPE evaluated by researchers
- •Unsuitable for or reject systemic therapy of tumor
- •Estimated survival of more than 3 months. 6.18 years or older
排除标准
- •Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants
- •Be allergic to bevacizumab
- •Pregnant or lactating woman
- •Pleural or pericardial infection
研究组 & 干预措施
Bevacizumab
Bevacizumab 100 mg, intrapleural injection treating maliganant pleural or percardial effusion
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Lung cancer symptom
时间窗: Evaluated by lung cancer symptom scale 21-30 days after the treatment
次要结局
- response rate(Evaluate response rate 21-30 days after the treatment)
- Time to progression(1 year after the treatment of MPE.)
- Overall survival(1 year after the treatment of MPE)
- Number of Participants with Adverse Events(one months after the treatment of MPE)
研究者
Haihong Yang, MD, Pricipal investigator
Deputy Chief Physician
Guangzhou Medical University