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This monocentric, prospective, observational study will evaluate the safety and efficacy of apatinib in combination with albumin binds paclitaxel and carboplatin or cisplatinum as first-line treatment for stage II-IV epithelial ovarian cancer followed by apatinib maintenance therapy in routine clinical practice. Eligible patients will be followed for approximately 20 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Experimental |
|
|
| Group2 | Experimental | 1.Adjuvant therapy: After primary cytoreductive surgery,patients will received adjuvant therapy: Apatinib:apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd; Abraxane:abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1; Cis-platinum or Carboplatin:cis-platinum or carboplatin one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1;carboplatin intravenous injection at a dose of AUC=5-6,d1. Adjuvant therapy is 3 cycles 3.maintenance treatment: After above treatment finished,patients will received aptinib for 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib Mesylate | Drug | apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | defined as the proportion of patients with no gross tumor tissue residual after interval cytoreductive surgery | approximately 2 years |
| Progression-free survival | defined as time from first administration of first-line therapy to documented disease progression | approximately 2 years |
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Inclusion Criteria:
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1.Age 18 - 75 years; 2.Histologically confirmed, stage II or IV epithelial ovarian carcinoma; 3.For Group1,patients with stage III-IV ovarian cancer who are considered unlikely to achieve satisfactory tumor reduction after preoperative evaluation by gynecological oncologists or not suitable for direct surgery are required; 4.Patients with at least one evaluable or measurable lesions as per RECIST version 1.1(CT scan length and diameter of tumor lesion≥10mm CT scan of lymph node lesion was short diameter≥15mm,scan slice thickness 5mm); 5.ECOG performance status (PS) 0 - 2; 6.Life expectancy of at least 12 weeks; 7.Patients with adequate organ function at the time of enrollment as defined below:
Blood routine examination standard:(without blood transfusion within 14 days before enrollment)
Biochemical examination shall meet the following standards:
BIL ≤ 1.5 times the upper limit of normal(ULN);
ALT and AST ≤ 3 ×upper limit of normal(ULN);
Serum creatinine Cr ≤ 1ULN;
Serum creatinine ALB ≥ 30g/L. 8.Women of childbearing age in the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients,and agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 8 months after the end of the study; males should agree to patients who must use contraception during the study period and within 8 months after the end of the study period.
9.Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Xiao, Doctor | Contact | 2292201 | 0592 | xiaolibohan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Xiao, Doctor | Zhongshan Hospital Xiamen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
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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 |
|---|---|
| C553458 | apatinib |
| D000068196 | Albumin-Bound Paclitaxel |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| Abraxane | Drug | abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1 |
|
| Cis Platinum | Drug | cis-platinum one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1 |
|
| Carboplatin | Drug | carboplatin one course will last 21 days.carboplatin intravenous injection at a dose of AUC=5-6,d1 |
|
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |