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Malignant Pleural Effusion or Ascites is a common complication of malignant tumor, The objective of this study is to compare the efficacy of Endostar/cisplatin with placebo/cisplatin in patients with malignant pleural effusion or ascites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENDOSTAR combined with cisplatin | Active Comparator |
| |
| Placebo combined with cisplatin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDOSTAR,cisplatin | Drug | After sufficient puncture and drainage or drainage, use Endo® (45mg/time in thoracic cavity, 60mg/time in abdominal cavity) + cisplatin (40mg/time) intracavitary injection, administration on 1, 4, and 7 days, 3 times as a course of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Puncture/drainage-Free Survival, PuFS | Compared with placebo combined with intracavitary cisplatin injection, use Puncture/drainage-Free Survival (Puncture/drainage-Free Survival, PuFS) as an indicator to evaluate Endo® combined with cisplatin intracavitary injection in the treatment of malignant pleural or ascites effusion Efficacy. | From the date of the end of experiment therapy to the next Puncture /drainage or death from any cause, up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shukui Qin, Doctor | Shanghai East Hospital of Tongji University | Study Chair |
| Jin Li, Doctor | Shanghai East Hospital of Tongji University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yan Xie | Nanjing | China |
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| Placebo , cisplatin | Drug | Placebo , cisplatin |
|
| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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