Apatinib for Advanced Sarcoma: Results From Multiple Institutions' Off-label Use
2018年4月6日 更新者:Peking University People's Hospital
The Effectivity and Toxicity of Methylsulfonic Apatinib for Extensively Pre-treated Advanced Sarcoma: a Multicentric Retrospective Study in China
Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced sarcoma after failure of standard multimodal Therapy.
Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2.
This study summarizes the experience of three Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated sarcoma.
研究概览
详细说明
The investigators retrospectively analysed files of patients with advanced sarcoma not amenable to curative treatment, who were receiving an apatinib-containing regimen between June 1, 2015 and December 1, 2016.
Fifty-six patients were included: 22 osteosarcoma, 10 Ewing's sarcoma, 3 chondrosarcoma and 21 soft tissue sarcoma.
研究类型
介入性
注册 (实际的)
56
阶段
- 不适用
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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-
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Beijing、中国、100044
- Musculoskeletal Tumor Center of Peking University People's Hospital
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Beijing、中国、100144
- Peking University Shougang Hospital
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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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 1) histologically confirmed high-grade sarcoma;
- 2) initial treatment in the orthopedic oncology departments of the three affiliated hospitals of Peking University;
- 3) tumors not amenable to curative treatment or inclusion in clinical trials;
- 4) unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy;
- 5) measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) [8];
- 6) Eastern Cooperative Oncology Group performance status 0 or 1 [9]; and 7) acceptable hematologic, hepatic, and renal function.
Exclusion Criteria:
- had been previously exposed to other TKIs;
- had central nervous system metastasis;
- had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
- had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on;
- had pleural or peritoneal effusion that needs to be handled by surgical treatment;
- combined with other infections or wounds
- were pregnant or breastfeeding.
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
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:osteosarcoma
all patients had been given apatinib alone
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Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.
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实验性的:Ewing sarcoma
Some of patients had been given apatinib alone while some of them had been given apatinib+everolimus
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Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.
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实验性的:soft tissue sarcoma
Some of the patients had been given apatinib alone while some of the patients had been given apatinib together with GT chemotherapy, which was gemcitabine 1000 mg/m2 d1,8 and docetaxel 75 mg/m2 d8 once every 21 day.
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Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.
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实验性的:Chondrosarcoma
Patients were given apatinib alone
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Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.
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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 |
---|---|---|
objective response rate
大体时间:3 month
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CR+PR accroding to RECIST 1.1
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3 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
progression-free survival, PFS
大体时间:4 months and 6 months
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PFS was defined as time from the start of using apatinib until disease progression or death, whichever occurred first.
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4 months and 6 months
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duration of response, DOR
大体时间:4 months
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The time from appearance of response or stable disease to progression or death was thus considered the DOR
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4 months
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Overall Survival,OS
大体时间:12 months
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OS was defined as time from the start of using apatinib until death.
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12 months
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toxicity
大体时间:12 months
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accroding to the Common Terminology Criteria for Adverse Events 4.0
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12 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。
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 (实际的)
2015年6月1日
初级完成 (实际的)
2016年12月31日
研究完成 (实际的)
2017年2月1日
研究注册日期
首次提交
2018年3月31日
首先提交符合 QC 标准的
2018年3月31日
首次发布 (实际的)
2018年4月9日
研究记录更新
最后更新发布 (实际的)
2018年4月10日
上次提交的符合 QC 标准的更新
2018年4月6日
最后验证
2018年4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.
Methylsulfonic apatinib的临床试验
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Sun Yat-sen UniversityJiangsu Hengrui Pharmaceutical Co., Ltd.尚未招聘