Ovarian cancer
Conditions
Interventions
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Signed the Informed Consent Form; 2. Female aged 18 to 70 years; 3. Histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 4. Patients with platinum-resistant or refractory advanced recurrent or metastatic ovarian cancer previously treated with standard cisplatin regimens; 5. One of the following conditions according to the RECIST1.1 version or CA125 standard by GCIG : (1)diameter of measurable tumor increases by 20%; (2) any new focus; (3) CA125=2×ULN(if normal previously) , or CA125=2×LLN; 6. Intoleranting of cytoreductive surgery; 7. No considering other targeted drugs; 8. ECOG(Eastern Cooperative Oncology Group) 0~2; 9. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function ). For example: HB=80 g/L, ANC>1.5×109/LPLT>75×109/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 10. Patients must have a life expectancy of at least 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients allergy to apatinib and / or its excipients; 2. Not recovering from the toxicity to 0-1 degree(according to CTC AE 4 version); 3. Patients with poor blood pressure control (systolic blood pressure=140 mmHg, diastolic blood pressure> 90 mmHg ); 4. Patients whose routine urine tests indicate that urine protein = ++ or verifies that the 24-h urine protein quantitation = 1.0 g; 5. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening; 6. Patients with a long-term uncured wound or fracture; 7. Patients with uncontrolled metastasis in the central nervous system; 8. 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)<50%); 9. Patients with uncontrolled infection, thrombosis, bleeding risk and so on; 10. Patients with uncontrolled chronic diseases such as diabetes, hypertension, gastrointestinal ulcer, chronic hepatitis, mental illness, etc. 11. Having a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 12. Patients with basal cell carcinoma,Carcinoma in situ of the cervix and superficial bladder cancer; 13. Other situations that the researchers considered unsuitable for this study; 14. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 year survival rate ;2 year survival rate ;OS;DCR;ORR;Safety; | — |
Countries
China
Contacts
Public ContactQiang Wen
Zhejiang Cancer Hospital
Outcome results
None listed