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| Name | Class |
|---|---|
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
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To reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in the study of QL1101 and AvastinĀ® in patients with Non-squamous Non-small Cell Lung Cancer
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Control group | AvastinĀ® + paclitaxel/carboplatin:subjects are given 15 mg/kg AvastinĀ® on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1101 | Drug | targeted vascular endothelial growth factor (VEGF) monoclonal antibodies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The actual endpoint is best response seen during the study | 18 weeks |
| Number of circulating endothelial cell subsets | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The strength of intratumoral blood perfusion index(BV,BF,PS and MTT) | 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 |
| Disease control rate |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pilin Ma | Contact | 0086-531-83126996 | pilin.ma@qilu-pharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tainjin | China |
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| AvastinĀ® | Drug | targeted vascular endothelial growth factor (VEGF) monoclonal antibodies |
|
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| Paclitaxel | Drug | 175 mg/m2, IV following investigational product on day 1 of each 21 day cycle. |
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| Carboplatin | Drug | AUC 5 IV, following paclitaxel on day 1 of each 21 day cycle. |
|
DOR is defined as the time from the first tumor evaluation as CR or PR to the first evaluation as PD or death |
| 3 months, 6 months, 9 months, 1 year |
| Treatment-emergent adverse events | Assessment following therapy with either QL1101 or avastin | 18 week |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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