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The study was designed to evaluate the efficacy and safety of apatinib with albumin-bound paclitaxel in patients with platinum-resistant recurrent ovarian cancer.
The study is an open, one-arm, prospec will collect 35 patients with platinum-resistant recurrent ovarian cancer treated with apatinib with albumin-bound paclitaxel from 2019 to 2020 in Henan Cancer Hospital.Antiangiogenic treatments have been implicated to play a major role in ovarian cancer (OC). Apatinib, a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2), in combination with weekly paclitaxel, may improve clinical outcomes compared with apatinib or paclitaxel alone in patients with refractory or platinum-resistant ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| albumin-bound paclitaxel+apatinib | Experimental | albumin-bound paclitaxel:260mg/m2,q3w,d1 apatinib:500mg,qd,po |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albumin-bound paclitaxel | Drug | Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a microtubule inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival | through study completion, an average of 5 year |
| PFS | Progression-Free Survival | through study completion, an average of 5 year |
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Inclusion Criteria:
Exclusion Criteria:
1.Had prior exposure to apatinib or has known allegies to any of the excipients.
2.Patients with trauma, surgical history, gastrointestinal bleeding, and melena within 1 month prior to treatment.
3.Inadequately controlled hypertension. 4.History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1.
5.Imaging studies suggest that patients with tumors invading important blood vessels.
6.Symptomatic central nervous system (CNS) metastasis. 7.History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| C553458 | apatinib |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| Apatinib | Drug | a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2) |
|
| DCR | Disease Control Rate | Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months |
| 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 |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |