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Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration(SFDA:2011L00661) which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of andvanced non-small cell lung cancer who failed two lines of chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Active Comparator | Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Placebo Capsule | Placebo Comparator | Placebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib QD po. |
| |
| Placebo capsule |
| Measure | Description | Time Frame |
|---|---|---|
| enhanced CT/MRI scan | To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Refer to recist 1.1. | each 42 days up to disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | contain Serious Adverse Event To evaluate the safety of Anlotinib by CTC AE 4.0 | each 21 days up to intolerance the toxicity(or PD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bao hui Han, doctor | Chest hospital affiliated to Shanghai jiaotong university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
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| Drug |
Placebo QD po. |
|
| Beijing chest hospital,capital medical university |
| Beijing |
| Beijing Municipality |
| 101149 |
| China |
| Xinqiao Hospital, Third Military Medical University | Chongqing | Chongqing Municipality | 400037 | China |
| Hunan Province Tumor Hospital | Changsha | Hunan | 410013 | China |
| The First Affiliated Hospital of Suzhou University | Suzhou | Jiangsu | 215006 | China |
| Jilin province tumor hospital | Changchun | Jilin | 130000 | China |
| Shandong Province Tumor Hospital | Jinan | Shandong | 250117 | China |
| Chest hospital affiliated to Shanghai jiaotong university | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| West China Hospital,Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| The first affiliated hospital,zhejiang university | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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