To Predict Efficacy by Detecting Circulating Endothelial Cell Subsets and Blood Perfusion Parameters Changes in Vivo Tumor in Study of QL1101 and Avastin® in Patients With Non-squamous Non-small Cell Lung Cancer
2017年6月21日 更新者:Qilu Pharmaceutical Co., Ltd.
To reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in the study of QL1101 and Avastin® in patients with Non-squamous Non-small Cell Lung Cancer
研究概览
详细说明
The study is QL1101-002 additional research, by detecting the blood circulating endothelial cells and blood perfusion parameters change within tumors early prediction efficacy and drug resistance.
研究类型
观察性的
注册 (预期的)
15
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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Tainjin、中国
- 招聘中
- Tianjin Medical University Cancer Institute and Hospital
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首席研究员:
- Kai Li, Professor
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接触:
- Kai Li
- 电话号码:0086-22-81351613
- 邮箱:likai5@medmail.com.cn, likqupp@yahoo.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 至 75年 (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
概率样本
研究人群
The patients with Non-squamous Non-small Cell Lung Cancer,who should meet the eligibility criteria.Because the study is QL1101-002 additional research, all people meet QL1101-002 clinical research requirements
描述
Inclusion Criteria:
- Aged ≥18 years and ≤75 years;
- Patients with histologically or cytologically confirmed inoperable locally advanced (Stage IIIb, not suitable for multidisciplinary treatment), metastatic (Stage IV), or relapsed non-squamous cell non-small cell lung cancer. Diagnostic result of non-squamous cell non-small cell lung cancer obtained based on sputum cytology should be immunohistochemically confirmed. If a variety of tumor ingredients are mixed, the main cell types should be classified;
- ECOG score of 0-1 points;
- At least one measurable lesion can be evaluated according to RECIST1.1 criteria;
- Patients who have not received systemic anti-tumor therapy of locally advanced or metastatic non-squamous non-small cell lung cancer (if the subject received adjuvant therapy after completing the radical treatment of early non-small cell lung cancer, but then the disease relapsed, the subject can be enrolled. In this case, the end time of the adjuvant therapy is required to be more than 6 months from the time of the first administration of this study, and various toxic reactions resulting from the adjuvant therapy should have recovered (≤ Grade 1 by CTCAE 4.03 criteria, except for alopecia);
- Expected survival time ≥24 weeks;
Exclusion Criteria:
- Central squamous cell carcinoma, and mixed gland squamous cell carcinoma with squamous cell as the main ingredient;
- ALK fusion gene is known to be positive;
- Medical history or examination shows thrombotic disease within 6 months prior to screening;
- Imaging shows signs of tumor invasion of large vessels, and the investigator or radiologist must exclude patients whose tumor has been completely close to or surrounded or invaded the lumen of large vessels (e.g., the superior pulmonary artery or superior vena cava);
- Patients with a past history of symptomatic brain metastases or meningeal metastases, or spinal cord compression;
- Patients who received palliative radiotherapy for bone lesions outside the chest within 2 weeks prior to the first dose of the study drug;
- Patients who received major surgical procedures (including thoracotomy), or suffered from major trauma (such as fractures) within 28 days
- prior to screening, or need to undergo major surgery during the expected study treatment period;
- Patients who received a minor surgical procedure within 48 hours prior to the first treatment with Anivitis® QL1101 (the investigator judges whether there is bleeding tendency);
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 |
干预/治疗 |
|---|---|
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Experimental group
QL1101 + paclitaxel/carboplatin:subjects are given 15 mg/kg QL1101 on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles.
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靶向血管内皮生长因子 (VEGF) 单克隆抗体
175 mg/m2, IV following investigational product on day 1 of each 21 day cycle.
AUC 5 IV, following paclitaxel on day 1 of each 21 day cycle.
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Control group
Avastin® + paclitaxel/carboplatin:subjects are given 15 mg/kg Avastin® on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles.
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靶向血管内皮生长因子 (VEGF) 单克隆抗体
其他名称:
175 mg/m2, IV following investigational product on day 1 of each 21 day cycle.
AUC 5 IV, following paclitaxel on day 1 of each 21 day 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 |
|---|---|---|
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客观反应率
大体时间:18周
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实际终点是研究期间看到的最佳反应
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18周
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Number of circulating endothelial cell subsets
大体时间:different time points before and after one week of treatment of QL1101 or avastin, an expected average of 2 weeks
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To detect the number of circulating activated endothelial cell (aCECs) by flow cytometry
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different time points before and after one week of treatment of QL1101 or avastin, an expected average of 2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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疾病控制率
大体时间:3个月、6个月、9个月、1年
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DOR 定义为从第一次肿瘤评估为 CR 或 PR 到第一次评估为 PD 或死亡的时间
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3个月、6个月、9个月、1年
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The strength of intratumoral blood perfusion index(BV,BF,PS and MTT)
大体时间:different time points before and after 3 weeks of treatment QL1101 or avastin, an expected average of 6 weeks
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To detect the strength of intratumoral blood perfusion index(BV,BF,PS and MTT) by CT perfusion imaging
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different time points before and after 3 weeks of treatment QL1101 or avastin, an expected average of 6 weeks
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Treatment-emergent adverse events
大体时间:18 week
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Assessment following therapy with either QL1101 or avastin
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18 week
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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)
2017年3月1日
初级完成 (预期的)
2018年6月12日
研究完成 (预期的)
2018年12月10日
研究注册日期
首次提交
2017年6月20日
首先提交符合 QC 标准的
2017年6月21日
首次发布 (实际的)
2017年6月22日
研究记录更新
最后更新发布 (实际的)
2017年6月22日
上次提交的符合 QC 标准的更新
2017年6月21日
最后验证
2017年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- QL1101
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.
非小细胞肺癌的临床试验
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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
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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
QL1101的临床试验
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Second Affiliated Hospital, School of Medicine,...Shanghai Junshi Bioscience Co., Ltd.; Qilu Pharmaceutical Co., Ltd.未知
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National Cancer Institute (NCI)主动,不招人复发性输卵管癌 | 复发性卵巢癌 | 复发性原发性腹膜癌 | 卵巢透明细胞囊腺癌 | 卵巢子宫内膜样腺癌 | 卵巢浆液性囊腺癌 | 子宫内膜透明细胞腺癌 | 子宫内膜浆液性腺癌 | IIIA 期输卵管癌 AJCC v7 | IIIA 期卵巢癌 AJCC v6 和 v7 | IIIA 期原发性腹膜癌 AJCC v7 | IIIB 期输卵管癌 AJCC v7 | IIIB 期卵巢癌 AJCC v6 和 v7 | IIIB 期原发性腹膜癌 AJCC v7 | IIIC 期输卵管癌 AJCC v7 | IIIC 期卵巢癌 AJCC v6 和 v7 | IIIC 期原发性腹膜癌 AJCC v7 | IV 期输卵管癌 AJCC v6 和 v7 | IV 期卵巢癌 AJCC v6 和 v7 | IV... 及其他条件美国
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M.D. Anderson Cancer Center招聘中软骨肉瘤 | 晚期恶性实体瘤 | III 期子宫体癌 AJCC v8 | IV 期子宫体癌 AJCC v8 | IVA 期子宫体癌 AJCC v8 | IVB 期子宫体癌 AJCC v8 | 临床 III 期皮肤黑色素瘤 AJCC v8 | 病理 IIIB 期皮肤黑色素瘤 AJCC v8 | 病理学阶段 IIIC 皮肤黑色素瘤 AJCC v8 | 病理IIID期皮肤黑色素瘤AJCC v8 | 复发性卵巢高级别浆液性腺癌 | 病理学 III 期皮肤黑色素瘤 AJCC v8 | 病理 IIIA 期皮肤黑色素瘤 AJCC v8 | 临床 IV 期皮肤黑色素瘤 AJCC v8 | 病理学 IV 期皮肤黑色素瘤 AJCC v8 | 晚期黑色素瘤 | 难治性黑色素瘤 | 难治性卵巢透明细胞腺癌 及其他条件美国
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)招聘中
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)招聘中复发性输卵管癌 | 复发性卵巢癌 | 复发性原发性腹膜癌 | 卵巢子宫内膜样腺癌 | 卵巢透明细胞腺癌 | 输卵管透明细胞腺癌 | 输卵管子宫内膜样腺癌 | 输卵管浆液性腺癌 | 卵巢浆液性腺癌 | 原发性腹膜浆液性腺癌 | 输卵管癌肉瘤 | 卵巢癌肉瘤 | 原发性腹膜癌肉瘤 | 原发性腹膜透明细胞腺癌 | 原发性腹膜子宫内膜样腺癌美国
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National Cancer Institute (NCI)主动,不招人卵巢子宫内膜样腺癌 | 原发性腹膜高级别浆液性腺癌 | 输卵管子宫内膜样腺癌 | 铂类耐药输卵管癌 | 铂类耐药原发性腹膜癌 | 卵巢高级别浆液性腺癌 | 铂类耐药卵巢癌 | 输卵管高级别浆液性腺癌美国, 加拿大