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Malignant ascites often has a profound impact on the quality of life of cancer patients. Current treatments,including dietary, medical, and procedural are often temporary and unsatisfactory options in patients approaching the end of life. Intraperitoneal bevacizumab for the palliation of malignant ascites might be a novel choice for refractory malignant ascites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bevacizumab | Experimental | The study evaluate 4 dose level of bevacizumab:2.5mg /kg;5 mg /kg;7.5mg /kg; 1.25mg /kg; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | participants will be followed for the duration of hospital stay, an expected average of 1 week | during the treatment in the hospital,an expected average of 1 week |
| Maximum tolerated dose | during the treatment in the hosptital | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | ultrasound will be performed every week for efficacy evaluation | 1 week |
| time to treatment failure(TTF) | the follow-up visit of time to TTF will be performed every 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen, M.D. | Contact | 861088196561 | lin100@medmail.com.cn | |
| Jifang Gong, M.D. | Contact | 861088196561 | gongjifang@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Active, not recruiting | Beijing | Beijing Municipality | 100142 | China | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33616416 | Derived | Kou F, Gong J, Li Y, Li J, Zhang X, Li J, Shen L. Phase I study of intraperitoneal bevacizumab for treating refractory malignant ascites. J Int Med Res. 2021 Feb;49(2):300060520986664. doi: 10.1177/0300060520986664. |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 1 month |
| time to death(TTD) | TTD means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 2 months till death or lost | 2 months |
| Peking University Cancer Hospital |
| Recruiting |
| Beijing |
| Beijing Municipality |
| 100142 |
| China |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |