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
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT03195569
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
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);
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group Carboplatin 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. Control group Avastin® 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. Control group Paclitaxel 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. Experimental group QL1101 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. Experimental group Paclitaxel 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. Experimental group Carboplatin 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.
- Primary Outcome Measures
Name Time Method Objective response rate 18 weeks The actual endpoint is best response seen during the study
Number of circulating endothelial cell subsets 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
- Secondary Outcome Measures
Name Time Method The strength of intratumoral blood perfusion index(BV,BF,PS and MTT) 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
Disease control rate 3 months, 6 months, 9 months, 1 year DOR is defined as the time from the first tumor evaluation as CR or PR to the first evaluation as PD or death
Treatment-emergent adverse events 18 week Assessment following therapy with either QL1101 or avastin
Trial Locations
- Locations (1)
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tainjin, China