Ovarian cancer
Conditions
Interventions
One arm:Apatinib was given orally 250mg/day
Sponsors
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old, female patients; 2. ECOG score 0-2; 3. Clinical diagnosis of epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer; 4. Received platinum-containing regimen treatment after surgery, and the disease recurrence/progression during the platinum-containing regimen treatment or the time from platinum-containing treatment (at least 4 cycles) to disease recurrence/progression is less than 6 months; 5. The patient has at least one measurable lesion (assessment standard: Response Evaluation Criteria in Solid Tumors 1.1); 6. The main organs function normally as the following standards: (1) The standard of routine blood examination should meet: 1) The number of neutrophils (ANC) >=1.5x10^9/L; 2) Platelet count (PLT) >=90x10^9/L; 3) Hemoglobin (Hb) >=90 g/L; (2) Biochemical inspection must meet the following standards: 1) Total bilirubin (TBIL) =50ml/min (Cockcroft-Gault formula); 7. No blood transfusion or blood products, no correction with G-CSF and other hematopoietic stimulating factors within 14 days; 8. The expected survival time>=12 weeks; 9. Women of childbearing age must have adopted reliable contraceptive measures or had a negative pregnancy test (serum or urine) within 7 days before enrollment, and are willing to adopt appropriate methods during the trial and 8 weeks after the last trial drug administration contraception. For men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and 8 weeks after the last trial drug administration; 10. The subjects voluntarily joined the study, signed an informed consent form, had good compliance.
Exclusion criteria
Exclusion criteria: 1) Previous exposure to other small molecule anti-angiogenesis drugs, such as apatinib, anlotinib, levatinib, sorafenib, regorafenib, etc.; for apatinib or Those who are allergic to excipients; 2) Has suffered from other malignant tumors within five years, except for cured skin basal cell carcinoma; 3) Uncontrollable hypertension (systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg, despite the best medical treatment); 4) Inability to swallow, chronic diarrhea and intestinal obstruction; 5) Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5ULN), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy. 6) Past severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval =450ms for males and =470ms for females); according to NYHA standards, grade ? to ? cardiac function Insufficiency, or cardiac color Doppler ultrasound examination reveals that the left ventricular ejection fraction (LVEF) is less than 50%; 7) Urine routine test indicates urine protein =++ or 24-hour urine protein quantitative =1.0 g; 8) Obvious hemoptysis or hemoptysis of half a teaspoon (2.5ml) or more in the 2 months before treatment with apatinib; 9) Significant clinically significant bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above, occurred within 3 months before treatment with apatinib; 10) Have received strong CYP3A4 inhibitors (such as itraconazole, clarithromycin, voriconazole, telithromycin, saquinavir, ritonavir, etc.) treatment within 7 days before starting apatinib treatment, or participate Those who have received strong CYP3A4 inducers (dexamethasone, phenytoin, carbamazepine, rifampin, phenobarbital, rifapentine, etc.) in the 12 days before the study; 11) Arterial/venous thrombosis events that occurred within 12 months before the start of apatinib treatment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis and pulmonary embolism; 12) According to the judgment of the investigator, there are accompanying diseases (such as severe diabetes, renal insufficiency, etc.) that seriously endanger the safety of the patient or affect the completion of the study; 13) Other.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month PFI rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Quality of life; | — |
Countries
China
Contacts
Public ContactShuzhen Wang, Hong Qu
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Outcome results
None listed