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| ID | Type | Description | Link |
|---|---|---|---|
| ALTER-L011 | Other Identifier | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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Based on the need of clinical practice of maintenance therapy for advanced NSCLC and the reliable data of third-line treatment for non-small cell lung cancer, the investigators designed a clinical study of anlotinib in maintenance therapy for advanced NSCLC to prospectively evaluate the efficacy of anlotinib in maintenance therapy for advanced NSCLC. Value, to provide a scientific basis for prolonging the survival time of patients with advanced NSCLC, improving the quality of life of patients in the course of treatment, and optimizing treatment strategies to a greater extent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anlotinib | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib Hydrochloride | Drug | Anlotinib hydrochloride capsule 12 mg, orally, once a day, oral before breakfast, according to the research program for 2 weeks, discontinued for 1 week. Patients with complete remission (CR), partial remission (PR) and stable disease (SD) continued to administer drugs until the disease progressed, intolerable toxicity or withdrawal was required. Patients with progression of illness (PD) discontinued their medication. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression free survival | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | through study completion, an average of 18 months |
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Inclusion Criteria:
Routine blood test ANC≥1.5 x 109/L; PLT≥100 x 109/L; Hb≥90g/L Blood biochemistry TBIL≤1.5 x ULN ALT and AST≤2 x ULN; for patients with liver metastases, ALT and AST ≤5 x ULN; BUN and Cr≤1.5 x ULN and creatinine clearance≥50 ml/min;LVEF≥50%; 12 lead electrocardiogram The Fridericia-corrected QTcF was < 450 ms for males and < 470 MS for females.
Exclusion Criteria:
Small cell lung cancer (including mixed small cell lung cancer and non-small cell lung cancer);Central squamous cell carcinoma, or non-small cell lung cancer with hemoptysis (> 50ml/d) or risk of massive bleeding;
Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor;
Medical history and combined history
According to the researcher's judgment, the patient may have other factors that may lead to the forced termination of the study, such as other serious diseases or serious laboratory abnormalities or other factors that may affect the safety of the subjects, or family or social factors that may affect the collection of test data and samples
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130013 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |