NCT03631459Unknown不适用
Safety and Effectiveness of Kanglaite Injection/Capsules for Treatment of Cancer Cachexia: A Prospective, Multicenter Real World Study of a Large Cohort of Chinese Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100,000
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
A prospective, multi-center real-world study of the effectiveness and safety of Kanglaita Injection/Capsule in Chinese patients with cancer cachexia
详细描述
This is a large national-based prospective, multi-center real-world observational study. Cancer cachexia patients scheduled for sequential treatment with Kanglaite injection and capsule between August 2018 and March 2020 at 640 participating hospitals will be recruited to evaluate the effectiveness and safety of Kanglaite.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathological or cytological diagnosis of lung, liver, pancreatic or stomach cancer; Patients scheduled to receive Kanglaite injection for 7 or more days, followed by Kanglaite capsule for 14 or more days; Patients willing to participate in this study and provide written informed consent.
排除标准
- 未提供
研究组 & 干预措施
Kanglaite Injection/Capsules
Kanglaite injection 200ml, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles
干预措施: Kanglaite Injection/Capsules (Drug)
结局指标
主要结局
Overall survival
时间窗: 2018 - 2020
Overall survival
次要结局
- Lean body mass(2018 - 2020)
- Grade of cachexia(2018 - 2020)
- Body weight(2018 - 2020)
- Patient-generated subjective global assessment (PG-SGA)(2018 - 2020)
- Numeric rating scale for appetite(2018 - 2020)
- Karnofsky performance status(2018 - 2020)
- Numeric rating scale for pain(2018 - 2020)
- Synergistic antitumor effect: Overall response rate(2018 - 2020)
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30(2018 - 2020)
- Synergistic antitumor effect: Disease control rate(2018 - 2020)
研究者
研究点 (2)
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