NCT02805166已完成4 期
The Multi-center,Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lung Cancer,Head and Neck Cancer,Colorectal Cancer,Ovarian Cancer and the Other Cancer Receiving Chemotherapy
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.0 个研究点目标入组 420 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 主要终点
- The severity of adverse event during at least three consecutive cycles chemotherapy
研究概览
简要总结
The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients with age ≥ 18 years
- •diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer
- •Karnofsky Performance Status ≥ 70
- •life expectancy of at least 3 months
- •Written informed consent are acquired
排除标准
- •uncontrolled infection,Temperature is 38.0 ℃ or higher
- •pregnancy
- •Other situations that investigators consider as contra-indication for this study
研究组 & 干预措施
PEG-rhG-CSF
Experimental
patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
The severity of adverse event during at least three consecutive cycles chemotherapy
时间窗: up to 30 days after the patient study completion
The occurrence rate of adverse event during at least three consecutive cycles chemotherapy
时间窗: up to 30 days after the patient study completion
次要结局
- the non-occurrence rate of grade IV neutropenia (ANC <0.5 x 10^9/L)during at least three consecutive cycles chemotherapy(through the study completion,an average of 5 months)
- the duration of grade IV neutropenia(ANC <0.5 x 10^9/L) during at least three consecutive cycles chemotherapy(through the study completion,an average of 5 months)
研究者
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