Ovarian cancer
Conditions
Interventions
Case series:Apatinib mesylate tablets for the maintain treatment
Sponsors
The Second Hospital of Dalian Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Pathological (including histological or cytological) diagnosis of non-mucinous epithelial ovarian carcinoma, the recurrence of at least with imaging ± CA12-5 clinically confirmed conditions, with the best histology or cytology, and the need to exclude other systems Primary tumors and not suitable for cytoreductive surgery again with measurable lesions (according to RECIST 1.1 standard); 3. Patients with platinum-sensitive relapse after re-application of platinum-based chemotherapy 4-6 cycles, the efficacy evaluation of non-PD patients; Note: platinum-sensitive relapse: first-line platinum chemotherapy after more than 6 months of disease progression (RECIST1.1 standard evaluation). 4. ECOG PS: 0-1 points; 5. Expected survival = March; 6. The main organs function properly; 7. Women of childbearing age who have not undergone cytoreductive surgery at the time of first visit have to undergo a pregnancy test (serum) within 7 days prior to enrollment and have a negative result and are willing to take the appropriate Method of contraception. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis of non-epithelial ovarian cancer 2. Pathological diagnosis of ovarian mucinous epithelial carcinoma 3. Imaging (CT or MRI) showed tumor lesions away from the large blood vessels = 5 mm, or there is invasion of local macrovascular tumors; 4. Patients with hypertension who are unable to fall below the normal range after treatment with antihypertensive drugs (systolic> 140 mmHg, diastolic> 90 mmHg); 5. With previous serious cardiovascular disease: myocardial ischemia or myocardial infarction grade ? or above, poorly controlled arrhythmia (including QTc interval men = 450 ms, women = 470 ms); according to the NYHA standard, III ~ IV Cardiac insufficiency, or cardiac ultrasonography revealed left ventricular ejection fraction (LVEF) 1.0g); 7. There was significant bleeding (vaginal bleeding, blood in the stool, hematuria, hemoptysis, etc.) within 2 months prior to enrollment or half a teaspoon (2.5 ml) or more of bleeding daily; 8. Patients with bleeding predisposition or those with an event of anastomotic / venous thrombosis within 12 months with coagulation abnormalities (INR> 1.5, APTT> 1.5 ULN) 9. Long-term, unhealed wounds or fractures; 10. Patients who have history of psychotropic substance abuse who can not be abstinent or who have mental disorders; 11. At the investigator's discretion, there are other serious patients who may endanger the patient's safety or affect the patient's companion disease that completed the study; 12. Patients with CNS metastases; 13. Who are allergic to platinum drugs; 14. Pregnant or lactating women; 15. Researchers think it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate(DCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR);Progression-free survival(PFS);CA125 level;Quality of life score(QoL); | — |
Countries
China
Contacts
Public ContactJiang Kui
The Second Hospital of Dalian Medical University
Outcome results
None listed