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The study is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy and failed.
Ovarian cancer is the third most common gynecological malignancy,just less than endometrial cancer and cervical cancer. Because most patients with advanced ovarian cancer can not get the ideal tumor cell reduction surgery, and multi-drug resistance often emerges after repeated chemotherapy,recurrent and metastatic ovarian cancer has become one of the major diseases that threaten women's health. There is strongly necessary to explore effective therapeutic drugs and means to improve prognosis of these patients and improve the quality of life. The study,as a double blind clinical trial ,is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy regimens and failed. A total of 60 patients with performance status 0-2 were enrolled in this study, and were randomly divided into two groups--one group of 40 patients receiving apatinib,and another of 20 patients receiving placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | apatinib 500 mg p.o. once daily |
|
| control group | Placebo Comparator | placebo p.o. once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib | Drug | Patients in experimental group will take 500mg apatinib daily orally,and patients in control group will take placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Time from randomization until disease progression or death | approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Time from randomization until death from any cause of death | approximately 2 years |
| Objective response rate (ORR) | Proportion of patients with reduction in tumor burden of a predefined amount |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Kai, Ph.D | Contact | 18111277629 | 250450418@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital | Recruiting | Chengdu | Sichuan | 600000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37185961 | Derived | Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| Placebos | Drug | Physical properties of placebos are consistent with apatinib |
|
| approximately 2 years |
| disease control rate (DCR) | the total proportion of patients who demonstrate a response to treatment | approximately 2 years |
| Quality of life (QoL) | As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30) | approximately 2 years |