An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer (AHEAD-G202)
2016年1月28日 更新者:Peking Union Medical College Hospital
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.
研究概览
地位
未知
条件
详细说明
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.
研究类型
观察性的
注册 (预期的)
300
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Beijing
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Beijing、Beijing、中国、100032
- 招聘中
- Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
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首席研究员:
- Xiao yi Li, Doctor
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接触:
- Lin Zhao, Master
- 电话号码:+86(10)69158315
- 邮箱:wz20010727@aliyun.com
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Advanced Metastatic Gastric Cancer
描述
Inclusion Criteria:
- 》18 years old
- Advanced Metastatic Gastric Cancer
- The doctor evaluate that patients had benefit from treatment
- The patients signed the written informed consent
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Apatinib
Apatinib Tablets: 850 mg,po, once daily , 28 days for a cycle
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Adverse Events
大体时间:1 years
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Treatment-related toxicities were graded according to Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
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1 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Overall survival
大体时间:1 years
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Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause.
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1 years
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Progression-free survival
大体时间:8 months
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A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death.
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8 months
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Objective response rate
大体时间:5 months
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Number of participants who achieve complete response or partial response.
Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 4 weeks following the date of the initial response.
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5 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Chunmei Bai, MD、Peking Union Medical College Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Li N, Bai C, Zhang R, Ma L, Ren X, Zhang J, Fu Z, Zhao L. Efficacy and safety of apatinib for the treatment of AFP-producing gastric cancer. Transl Oncol. 2021 Feb;14(2):101004. doi: 10.1016/j.tranon.2020.101004. Epub 2020 Dec 28.
- Wang X, Zhang R, Du N, Yang M, Zang A, Liu L, Yu J, Gao J, Zhang J, Fu Z, Ren Y, Ma L, Guo J, Li Q, Li X, Fan Z, Song X, Liu Z, Zhang Y, Li G, Yu Z, Diao J, Jia J, Liang F, Wang H, Sun J, Gao Y, Yang P, Bai C, Ren X, Zhong D. An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202). Ther Adv Med Oncol. 2020 Mar 19;12:1758835920905424. doi: 10.1177/1758835920905424. eCollection 2020.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年9月1日
初级完成 (预期的)
2018年3月1日
研究完成 (预期的)
2019年5月1日
研究注册日期
首次提交
2015年12月5日
首先提交符合 QC 标准的
2016年1月28日
首次发布 (估计)
2016年1月29日
研究记录更新
最后更新发布 (估计)
2016年1月29日
上次提交的符合 QC 标准的更新
2016年1月28日
最后验证
2016年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.