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临床试验/NCT03629691
NCT03629691已完成不适用

A Retrospective Study for Patients With Lung Metastatic Advanced Gastric Cancer or NSCLC Treated With Apatinib

The Affiliated Hospital of Qingdao University0 个研究点目标入组 187 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
187
主要终点
PFS (progression-free survival)

研究概览

简要总结

The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.

详细描述

Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database. All patients were with Karnofsky performance status ≥70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions. Cardiac disease and hemorrhagic disease were excluded. All patients had pre-therapy chest computed tomography (CT) prior to apatinib treatment, and follow-up chest CT at least every 4 weeks. The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here. Other patient demographic and clinical data, including age, gender; stage of disease, apatinib administered inclusion and withdrawal date, adverse events, oncologic clinical response, comorbid conditions, and smoking history, were retrieved from the CRIS database.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma
  • Multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University.
  • Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database.
  • All patients were with Karnofsky performance status over 70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions.

排除标准

  • Cardiac disease and hemorrhagic disease were excluded.
  • Patients with lung cavitation before apatinib treated.

结局指标

主要结局

PFS (progression-free survival)

时间窗: From February 1, 2015 to May 19, 2018 ,about 27 months

Evaluation of the oncologic clinical response was based on the alternate, modified method. We concluded that incorporating an assessment of cavitation when measuring target lesions might more accurately reflect changes in tumor volume. It was used for target lesions in which the longest diameter of any cavitation (zero if no cavity presented) was subtracted from the longest total diameter of the lesion, with each measurement taken in the same plane, to provide an alternate measure that was used to calculate the sum of measurements for all target lesions.

次要结局

  • LRC (duration of locoregional control )(From February 1, 2015 to May 19, 2018 , about 27 months)

研究者

申办方类型
Other
责任方
Sponsor

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