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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| Huai'an First People's Hospital | OTHER |
| Jiangsu Taizhou People's Hospital | OTHER |
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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 antinil hydrochloride versus pemetrexed in maintenance therapy for advanced NSCLC to prospectively evaluate the efficacy of antinil hydrochloride 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.
This study is planned to be carried out in Jiangsu regional multi-center. 83 cases are preliminarily expected to be included. The study started in December 2018 and ended in December 2019. It is expected that the trial will end in December 2020.
In the absence of such situations as withdrawal of informed consent, intolerance of drug toxicity and side effects, or inappropriateness for further trials, each participant's expected time for research and treatment will continue until radiographically confirmed tumor progression occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression free survival | 5 month |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | through study completion, an average of 18 month |
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Inclusion Criteria:
Routine blood test ANC is more than 1.5 x 109/L; PLT is more than 90 x 109/L; Hb > 90g/L Blood biochemistry TBIL is less than 1.5 x ULN ALT and AST < 2 *ULN; for patients with liver metastases, ALT and AST < 5 *ULN; BUN and CR were less than 1.5 x ULN and creatinine clearance was more than 50 ml/min.
Colour Sonography LVEF is more than 50%; 12 lead electrocardiogram The Fridericia-corrected QTcF was < 450 ms for males and < 470 MS for females.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongqian Shu, PhD | Contact | 00862568306428 | shuyongqian@csco.org.cn | |
| Yiqian Liu, PhD | Contact | 008613813804568 |
| Name | Affiliation | Role |
|---|---|---|
| Yongqian Shu, professor | JANGSU PROVINCE HOSPITAL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38968520 | Derived | Liu Y, Miao L, Chen X, Zhu X, Li Y, He J, Chen P, Dai S, Liu Z, Ma K, Wang N, Zhao Y, Chen N, Song W, Bai R, Cui J, Shu Y. Maintenance therapy with anlotinib after induction therapy with platinum-based chemotherapy for advanced non-small-cell lung cancer: A pooled analysis of 2 single-arm trials. Medicine (Baltimore). 2024 Jul 5;103(27):e38459. doi: 10.1097/MD.0000000000038459. |
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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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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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| Zhongda Hospital |
| OTHER |
| Yancheng City NO.1 People's Hospital | UNKNOWN |
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |