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The study is a multi-center, prospective, one-arm, phase II clinical trial. It is tend to examine the safety and efficacy of combining abraxane(albumin-bound paclitaxel) and bevacizumab to treat patients with recurrent, platinum-resistant primary epithelial ovarian cancer, fallopian tube cancer or peritoneal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| albumin-bound paclitaxe combined with bevacizumab biosimilar | Experimental | albumin-bound paclitaxel, 260mg/m2,ivdrip,D1,once every three weeks bevacizumab biosimilar, 10mg/kg,ivdrip,D1, once every three weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albumin-bound paclitaxe combined with bevacizumab biosimilar | Drug | albumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; objective response rate (ORR) = CR+PR | Assessed at the end of 6 cycle(each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month progression-free survival rate | the percentage of participants with no progression event at 6 months after starting study treatment | assessed up to 6 months |
| progression-free survival | PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beihua Kong | Contact | 18560081888 | kongbeihua@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| up to 3 years |
| overall survival | Overall survival is defined as the time from treatment start until death from any cause | assessed up to 3 years |
| Disease control rate | the percentage of complete and partial response as well as stable disease | Assessed at the end of 6 cycle(each cycle is 21 days) |
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |