ovarian cancer
Conditions
Interventions
Case series:Alternate oral 500mg, 250mg apatinib
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study and signed informed consent; 2. Aged > 18 years; 3. Histologically confirmed high-grade serous/endometrial or high-grade serous/endometrial-like epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer; 4. FIGO stage is III or IV; 5. Previous surgical criteria (in accordance with one of them): postoperative residual disease status; stage III/IV patients undergo intermittent cytoreductive surgery, regardless of residual disease status; 6. Previous chemotherapy criteria: (1) Patients who have undergone intraperitoneal chemotherapy (cisplatin only); (2) First-line chemotherapy with at least 6 cycles but no more than 9 cycles of platinum-containing chemotherapy ( only Paclitaxel (135-175 mg/m2) combined with carboplatin (AUC 5) chemotherapy; (3) Patients undergoing Intermittent tumor reduction surgery should receive at least 2 cycles of platinum-containing chemotherapy before and after surgery; (4) The patient is assessed by the investigator to obtain complete tumor remission (CR) or partial remission (PR) after first-line platinum-containing chemotherapy. This evaluation needs to be performed after at least 3 chemotherapy cycles; (5) After the end of chemotherapy, the CA-125 level should be 95% within the normal range or in the first-line chemotherapy course and last for at least 7 days (the increase of CA-125 before enrollment should not exceed the CA-125 level after the end of chemotherapy) 15%); (6) Patients must complete the enrollment within 12 weeks from the first day of the last cycle of chemotherapy; 7. ECOG body status score is 0 or 1; 8. Good organ function: (1) Neutrophil count =1500/ul; (2) Platelets =100,000/ul; (3) Hemoglobin =10g/dl; (4) Serum creatinine = 1.5 times the upper limit of normal or creatinine clearance = 60ml / min; (5) Total bilirubin = 1.5 times the upper limit of normal value or direct bilirubin = 1.0 times the upper limit of normal value; (6) AST and ALT = 2.5 times the upper limit of normal value, liver transfer must be = 5 times the upper limit of normal value; 9. Ability to comply with the program; 10. The toxic side effects of any previous chemotherapy have been restored to =CTCAE1 level or baseline level.
Exclusion criteria
Exclusion criteria: 1. Epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer diagnosed as serous, clear cell subtype; 2. Have been diagnosed: mucinous, clear cell subtype of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer; 3. Have received maintenance treatment for any medication; 4. A history of gastrointestinal perforation or major surgery within 4 weeks prior to enrollment; 5. During the first 6 months of enrollment, there were events of venous/venous thrombosis, such as cardiovascular-cerebral vascular (including transient ischemic attack) and deep vein thrombosis (Except for those who have recovered due to the venous thrombosis caused by pre-chemotherapy) and pulmonary embolism; 6. Those with active bleeding or bleeding tendency; 7. There is hypertension that cannot be controlled by drugs; 8. Urine routine indicates more than urinary protein 2+; 9. Previous chemotherapy caused grade 3 anemia, neutropenia, thrombocytopenia, and lasted for more than 4 weeks; 10. Patients who underwent ascites drainage 4 weeks before enrollment; 11. Untreated or uncontrolled brain metastases or meningeal metastases; 12. Invasive cancer other than ovarian cancer within 5 years prior to enrollment (except for treated cervical carcinoma in situ, non-melanoma and ductal carcinoma in situ); 13. As judged by the investigator, there is a concomitant disease that seriously harms the patient's safety or affects the patient's completion of the study; 14. pregnant or lactating women; 15. Correct QT interval > 470msec; if the patient has a prolonged QT interval, but the investigator's study evaluates that the prolongation is due to a cardiac pacemaker (and no other abnormalities in the heart), it is necessary to discuss with the sponsor's researcher to determine if the patient is Suitable for group study; 16. Those who are known to be sensitive to active or inactive ingredients of drugs with similar chemical structures of apatinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;TFST; | — |
Countries
China
Contacts
Public ContactXu Qin
Fujian Provincial Cancer Hospital
Outcome results
None listed