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Malignant ascites is a severe complication of many types of human cancer. Animal and clinical analyses have shown that angiogenesis plays a critical role in the formation of malignant ascites. Therefore, drugs such as apatinib that target angiogenesis may control the development of malignant ascites. The study is to evaluate the efficacy and safety of apatinib in patients with refractory malignant ascites.
The study is to investigate the efficacy and safety of apatinib in patients with refractory malignant ascites. A total of 120 patients with performance status 0-2 were enrolled in this study and 500mg apatinib tablets were administered orally, once daily until disease progression or intolerable toxicity or patients withdrawal of consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 500mg apatinib | Experimental | Patients will receive 500mg of apatinib tablet orally, once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Patients will take 500mg apatinib daily orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The repeat paracentesis response rate (proportion of subjects who have a doubling of baseline time to repeat paracentesis) | 12 weeks after initiation of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The time to the need for the first repeat abdominal paracentesis after the start of apatinib therapy as compared with historical control data. | 12 weeks after initiation of study treatment | |
| The mean number of paracentesis procedures required in each patient over the course of three months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiong Wu, M.D. Ph.D. | Contact | +86-552-3074480 | byzlnk@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qiong Wu | Recruiting | Bengbu | Anhui | China |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| 12 weeks after the initiation of study treatment |
| The effect of apatinib therapy on quality of life in patients with malignant ascites by using EORTC QLQ-C30 V3.0. | 12 weeks after the initiation of study treatment |