Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC
2018年1月25日 更新者:Zigong No.1 Peoples Hospital
Clinical Study of Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC After Failure of Platinum-based Double-drug Therapy
In order to explore a new treatment strategy for patients with failed NSCLC platinum-containing double-drug therapy, this study was to investigate the clinical efficacy of apatinib in combination with docetaxel for patients with advanced NSCLC after failure of platinum-based regime
研究概览
研究类型
介入性
注册 (预期的)
20
阶段
- 阶段2
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。
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
描述
Inclusion Criteria:
- ECOG 0-2;
- Expected survival of not less than 12 weeks;
- The first line of platinum-containing chemotherapy, pathologically confirmed IIIB, IV non-small cell lung cancer, with measurable lesions (according to the RECIST 1.1 standard, CT lesion tumor diameter ≥ 10mm, lymph node lesion CT scan diameter ≥ 15mm, measurable lesions have not received radiotherapy, local treatment such as freezing)
- The main organs function properly
- Women of childbearing age must have had reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and are willing to take appropriate measures 8 weeks after and during the last administration of the test drug contraception. In the case of males, consent is to be given to contraception or surgical sterilization 8 weeks after and during the last administration of the test drug;
- Participants volunteered to join the study and signed informed consent form, with good compliance and follow-up.
Exclusion Criteria:
- Imaging (CT or MRI) showed tumor lesions away from the large blood vessels ≤ 5mm, or the presence of invasive central local blood vessels of the central tumor; or showed the presence of significant lung empty or necrotic tumors;
- Uncontrolled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal drug therapy);
- Has the following cardiovascular disease: Myocardial ischemia or myocardial infarction with grade II or higher, poorly controlled arrhythmia (including QTc intercourse men ≥ 450ms, women ≥ 470ms); NYHA class III-IV cardiomyopathy, Or cardiac ultrasound examination prompted left ventricular ejection fraction (LVEF) <50%;
- Hemoptysis (INR> 1.5 or Prothrombin Time (PT)> ULN + 4 seconds or APTT> 1.5ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- In the first 2 months before enrollment, there is obvious slightly blood, or daily hemoptysis volume of 2.5ml or more;
- Within 3 months prior to enrollment, significant clinically significant bleeding symptoms or definite bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ at baseline, and above, or vasculitis;
- Incidence of arterial / venous thrombosis within the first 12 months of enrollment such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- Known hereditary or acquired bleeding and thrombophilia (eg hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc);
- Factors that significantly affect the absorption of oral drugs, such as non-swallowing, chronic diarrhea and intestinal obstruction;
- Urine routine urinary protein ≥ ++, or confirmed 24-hour urinary protein content ≥ 2.0g;
- Previous or concurrent with other unhealed malignancies, except for those having had a cure for cutaneous basal cell carcinoma, carcinoma of the cervix, and superficial bladder cancer;
- Pregnant or lactating women; Reproductive patients who are unwilling or unable to take effective contraception;
- The investigators determine other situations that may affect clinical research and outcome decisions.
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:不适用
- 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:apatinib combine with docetaxel
Docetaxel, 60 mg / m2, d1, iv + apatinib 500mg, po, qd
|
apatinib mesylate tablets 500mg, po, qd, continued until the next cycle, taking on an empty stomach (daily taken at the same time), every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment, apatinib has been taken until the disease progresses, intolerable toxicity.
其他名称:
Docetaxel, 60 mg / m2, d1, iv ,every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment
|
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 |
|---|---|---|
|
反应率
大体时间:6个月
|
客观反应率
|
6个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PFS
大体时间:12 month
|
Progress-Free Survival
|
12 month
|
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:132100694 132100694, M.D.、Zigong No.1 People's Hospital
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 (预期的)
2018年2月1日
初级完成 (预期的)
2020年12月1日
研究完成 (预期的)
2021年12月1日
研究注册日期
首次提交
2018年1月21日
首先提交符合 QC 标准的
2018年1月25日
首次发布 (实际的)
2018年1月26日
研究记录更新
最后更新发布 (实际的)
2018年1月26日
上次提交的符合 QC 标准的更新
2018年1月25日
最后验证
2018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.
肺癌的临床试验
-
Taichung Veterans General Hospital完全的心脏毒性 | 非小细胞肺癌(MeSH术语:Carcinoma, Non-Small-Cell Lung) | 药物相关副作用和不良反应(MeSH术语) | 表皮生长因子受体酪氨酸激酶抑制剂台湾
-
Fondazione del Piemonte per l'Oncologia招聘中乳腺癌 | 卵巢癌 | 结直肠癌 | 黑色素瘤(皮肤癌) | 非小细胞肺癌(MeSH术语:Carcinoma, Non-Small-Cell Lung)意大利
Apatinib的临床试验
-
Guangzhou Virotech Pharmaceutical Co., Ltd.招聘中
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityJiangsu HengRui Medicine Co., Ltd.招聘中
-
The First Affiliated Hospital of Zhengzhou University招聘中