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临床试验/NCT02668380
NCT02668380Unknown不适用

An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Adverse Events

研究概览

简要总结

This is an Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer, the investigators opted to give patients for apatinib 850 mg once daily, 28 days for a cycle. To evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.

详细描述

In the last decade, front-line chemotherapy has been considered a standard therapeutic regimen for the extension of survival time in patients with metastatic gastric cancer (mGC). New evidence suggests that salvage chemo-therapies, as second-line treatments, may have a survival advantage when compared with best supportive care. After failure of second-line chemotherapy, the results of further treatment are poor, yielding response rates of 0% to 5% with no evidence of prolonged survival. Apatinib is a small-molecule VEGFR-2 tyrosine kinase inhibitor, Had been approved by the CFDA for the treatment of advanced gastric cancer, However, this study defines a variety of inclusion/exclusion criteria, efficacy and safety are not well reflect in the real world for the treatment of advanced gastric cancer. Therefore, an Open Label, Prospective, Multicentre, Non-interventional Study could evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • 》18 years old
  • Advanced Metastatic Gastric Cancer
  • The doctor evaluate that patients had benefit from treatment
  • The patients signed the written informed consent

排除标准

  • Apatinib has been confirmed for allergy sufferers
  • Pregnant or lactating women
  • Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)
  • Doctors think doesn't inclusion

结局指标

主要结局

Adverse Events

时间窗: 1 years

Treatment-related toxicities were graded according to Common Terminology Criteria Adverse Events (CTCAE) version 4.0.

次要结局

  • Objective response rate(5 months)
  • Overall survival(1 years)
  • Progression-free survival(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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