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This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial evaluating the efficacy and safety of Apatinib for third-line and later treatment of patients with small cell lung cancer.
Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE)and second-line therapy with topotecan has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and 2-year survival is less than 10%. There is no standard treatment recommendation for this group of patients who failed to second-line therapy and had good performance status. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine. And this clinical trial is designed to prospectively investigate the efficacy and safety of apatinib in recurrent SCLC patients in our center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib Mesylate tablet | Experimental | Patients received oral apatinib 500 mg in tablet once daily, a treatment cycle was defined as 28 days (4 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib Mesylate tablet | Drug | Apatinib 500 mg in tablet once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | up to 3 years | |
| Disease Control Rate | up to 3 years | |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| Measure | Description | Time Frame |
|---|---|---|
| tumor phosphorylated VEGFR2 (p-VEGFR2) expressions | baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yutao Liu, M.D. | Contact | +8613911901165 | 13911901165@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Yutao Liu, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32250517 | Derived | Liu Y, Hu X, Jiang J, Yang L, Zhou S, Liu P, Li J, Wang Y, Hao X, Shi Y. A Prospective Study of Apatinib in Patients with Extensive-Stage Small Cell Lung Cancer After Failure of Two or More Lines of Chemotherapy. Oncologist. 2020 May;25(5):e833-e842. doi: 10.1634/theoncologist.2019-0391. Epub 2020 Apr 6. |
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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 |
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| up to 3 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |