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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

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

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
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.
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.
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.
靶向血管内皮生长因子 (VEGF) 单克隆抗体
其他名称:
  • 贝伐单抗
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.

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
客观反应率
大体时间:18周
实际终点是研究期间看到的最佳反应
18周
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
To detect the number of circulating activated endothelial cell (aCECs) by flow cytometry
different time points before and after one week of treatment of QL1101 or avastin, an expected average of 2 weeks

次要结果测量

结果测量
措施说明
大体时间
疾病控制率
大体时间:3个月、6个月、9个月、1年
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
3个月、6个月、9个月、1年
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
To detect the strength of intratumoral blood perfusion index(BV,BF,PS and MTT) by CT perfusion imaging
different time points before and after 3 weeks of treatment QL1101 or avastin, an expected average of 6 weeks
Treatment-emergent adverse events
大体时间:18 week
Assessment following therapy with either QL1101 or avastin
18 week

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

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

QL1101的临床试验

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