NCT04060290已完成不适用
Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.14 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年5月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 14
- 主要终点
- Percentage and severity of Participants With Adverse Events (AEs)
研究概览
简要总结
This is a multi-center, Prospective, observational study，to evaluate the safety and influencing factors of albumin-bound paclitaxel in the real-world chinese population，and evaluate of the efficacy of albumin-bound paclitaxel in patients with malignant tumors and its impact on quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In patients with malignant tumor who have been treated with albumin-bound paclitaxel for the treatment.
排除标准
- 未提供
结局指标
主要结局
Percentage and severity of Participants With Adverse Events (AEs)
时间窗: 28 days after the end of the last chemotherapy cycle
percentage and CTC AE(v5.0) of AEs
次要结局
- Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)(From signing informed consent，assessed up to end of study (up to approximately 24months))
- evaluate patients' quality of life by the European Cancer Research and Treatment Tissue Cancer Quality Core Questionnaire EORTCQLQ-C30(From signing informed consent，assessed up to end of study (up to approximately 24months))
研究者
研究点 (14)
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