Ovarian cancer
Conditions
Interventions
Case series:Apatinib
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged 18 to 70 years; 2. Histologically or pathologically confirmed diagnosis of recurrent or metastatic ovarian cancer (including epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer); 3. At least treated with two standard chemotherapy regimens,and the latest treatment must be completed for at least 4 weeks before screening; 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version; 5. No considering other targeted drugs; 6. ECOG(Eastern Cooperative Oncology Group) :0~2; 7. Patients must have a life expectancy of at least 3 months; 8. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: HB=90 g/L, ANC>1.5×10^9/L, PLT>75×10^9/L, TBIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value (Liver metastasis: <5×ULN), and CR=1.25 ×ULN 9. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment; 10. Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. The level of CA125 rose but no tumor lesion in imaging examination; 2. Patients with poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg ); 3. Patients with stage II myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QT interval male = 450 ms, female = 470 ms) and Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and anticoagulation 5. Previous within 3 months there is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding, such as: bleeding risk of esophageal varices, local active ulcer lesions, fecal occult blood = ( ++ ) not in group; fecal occult blood (+ ), requiring gastroscopy 6. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening; 7. Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 8. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening; 9. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 10. Having a history of psychiatric abuse and can not quit or have mental disorders; 11. Participating in other clinical trials at least 4 weeks before screening; 12. Patients with basal cell carcinoma,Carcinoma in situ of the cervix and superficial bladder cancer; 13. Pregnant and lactating women; Other situations that the researchers considered unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 year survival rate ;2 year survival rate ;OS;ORR;ORR;Safety; | — |
Countries
China
Contacts
Public ContactLu Chen
Zhejiang Cancer Hospital
Outcome results
None listed