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临床试验/NCT04871997
NCT04871997已完成不适用

A Real-world Study: Efficacy and Safety of Anlotinib for Advanced Non-small Cell Lung Cancer

Qian Chu1 个研究点 分布在 1 个国家目标入组 373 人开始时间: 2019年7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
373
试验地点
1
主要终点
progression-free survival (PFS)

研究概览

简要总结

A real-world study: Efficacy and safety of Anlotinib for advanced non-small cell lung cancer:This study aims to observe and explore the efficacy and safety of anlotinib in patients with advanced non-small cell lung cancer in the real world, and to summarize the treatment experience of a broad population.

详细描述

A real-world study: Efficacy and safety of Anlotinib for advanced non-small cell lung cancer:This study aims to observe and explore the efficacy and safety of anlotinib in patients with advanced non-small cell lung cancer in the real world, and to summarize the treatment experience of a broad population.This study is a non-interventional, prospective, observational, real-world case study and all registered data are collected from real clinical practice cases. Adult patients diagnosed as advanced non-small cell lung cancer and treated with anlotinib were included. At least one tumor lesion has not been subjected to local treatment such as irradiation in the past, and can be accurately measured, the longest diameter is ≥10 mm.The primary endpoint was progression-free survival (PFS) and the secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety.If the last patient reaches the main evaluation index or has intolerable toxic reaction, the observation will be finished, and the first one will prevail.Through Electronic Data Capture System (EDC) system, electronic case report form (eCRF) is used to replace paper-based case report form to collect and manage clinical trial data.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: ≥18 years old, no gender limit.
  • Diagnosed as advanced non-small cell lung cancer.
  • At least one tumor lesion has not been subjected to local treatment such as irradiation in the past, and can be accurately measured, the longest diameter is ≥10 mm.
  • Doctors evaluate the benefits of receiving Anlotinib treatment.
  • The patient voluntarily joins the project and signs the informed consent. If any of the above items is "No", the patient is not suitable for this study.

排除标准

  • Those who have been confirmed to be allergic to anlotinib and/or its excipients.
  • Patients with anlotinib contraindications.

结局指标

主要结局

progression-free survival (PFS)

时间窗: 2019.7-2022.7

the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

次要结局

  • overall survival (OS)(2019.7-2022.7)
  • objective response rate (ORR)(2019.7-2022.7)
  • disease control rate (DCR)(2019.7-2022.7)

研究者

发起方
Qian Chu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Qian Chu

Professor

Tongji Hospital

研究点 (1)

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