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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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The aim of the study is to evaluate the safety and efficacy of apatinib mesylate tablets and chemotherapy drug Irinotecan in treatment of recurrent SCLC stage IIIB&IV patients. It is a randomized controlled clinical trial.
Apatinib mesylate is a new inhibitor of VEGFR-2 tyrosine kinase targeting the intracellular ATPbinding site of the receptor.
This research needs participants satisfied following criteria:
The primary goal of this research choose ORR, DCR and adverse effects as main curative effect criteria. PFS, OS and QoL as secondary curative effect criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Patients use Apatinib Mesylate tablets combined with Irinotecan. |
|
| controlled group | Active Comparator | Patients use Irinotecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib Mmesylate tablets 250mg/d, po, there's totally 4-6 cycles(21days per cycle) |
|
| Measure | Description | Time Frame |
|---|---|---|
| duration of treatment | time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib | two years |
| Measure | Description | Time Frame |
|---|---|---|
| progress free survival and overall survival | Secondary study endpoint | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Zhang, Vice Director | Contact | 010-89509281 | bjchzhanghui@163.com |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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experimental group: Irinotecan 80mg/m2 d1,d8 vi, apatinib mesylate tablets(250mg/d) po, 4-6 cycle(21d per cycle); controlled group: Irinotecan 80mg/m2 d1,d8 vi, 4-6 cycle(21d per cycle);
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| Irinotecan | Drug | Irinotecan 80mg/m2 d1, d8, vi, there's totally 4-6 cycles(21days per cycle) |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |