Ovarian cancer
Conditions
Interventions
study group:Flzuoparib 100mg bid apatinib 375mg qd
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily joined the study and signed the informed consent ; 2. Age = 18 years (calculated by the day of informed consent) 3. Histopathologically confirmed, newly diagnosed (FIGO stage III or IV) or platinum-sensitive recurrent high-grade serous/endometrioid (=2 grade) epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer 4. Completed at least 4 cycles of platinum-containing chemotherapy, and the last platinum-containing chemotherapy reached SD (tumor shrinkage) 5. BRCA1/2 gene mutation 6. The time from the end of the latest chemotherapy to the time before administration should not exceed 8 weeks. - During or after the completion of platinum-based chemotherapy, other clinical investigational drugs are not allowed to be used at the same time, and other treatments other than endocrine therapy drugs are not allowed - Bevacizumab combination therapy is allowed during chemotherapy 7. The function of vital organs meets the following requirements: ? Adequate bone marrow reserve: absolute neutrophil count =1,500/mm3 or =1.5 × 10^9/L, platelet count =90,000/mm3 or =90 × 10^9/L, hemoglobin =9 g /dL ? Kidney: creatinine clearance =50 mL/min ? Liver: bilirubin =1.5 times upper limit of normal (ULN), aspartate and alanine aminotransferase (AST and ALT) = 2.5 × ULN, if there is liver metastasis, =5.0 × ULN ? Heart: left ventricular ejection fraction (left ventricular ejection fraction, LVEF) = 50% ? Serum creatinine = 1.5 times ULN 8. Fertile subjects must have a blood pregnancy test within one week before the first dose and the result is negative, and must agree to use a medically approved contraception during the study treatment and within 6 months after the last dose of the study drug measures (such as IUDs, birth control pills, or condoms) and must be non-nursing. 9. ECOG PS:0~1; 10. Patients with prior treatment with PARP inhibitors, except fuzuloparib, is allowed
Exclusion criteria
Exclusion criteria: 1. Patients with other uncured malignancies either concurrently or within the past 5 years, except for cured skin basal cell carcinoma and thyroid cancer 2. Patients with untreated metastases to central nervous system— patients who have received previous systemic and radical treatment for metastasis to brain or meninges (radiotherapy or surgery) can be enrolled if radiological results confirm a stable disease of > 1 month and the patients have stopped systemic hormonal therapy (> 10 mg/day of prednisone or equivalent) for more than 2 weeks 3. Patients with prior fuzuloparib treatment 4. Not able to swallow pills normally, or have abnormal gastrointestinal function affecting drug absorption as judged by the researcher; 5. Patients with recent ileus, gastrointestinal perforation (within the last 3 months) 6. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration 7. Patients with uncontrolled cardiac symptoms or diseases, such as: (1) NYHA Class II or greater heart failure (2) unstable angina (3) myocardial infarction within the past year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) QTc > 470 ms 8. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), bleeding tendency or receiving thrombolytic therapy are allowed to receive low-dose low-molecular weight heparin or oral aspirin preventive anticoagulant therapy during the study; 9. Have clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before the first medication, such as gastrointestinal bleeding, bleeding gastric ulcer, or vasculitis, etc. If the stool occult blood is positive during the baseline period, re-examination can be performed. If it is still positive, combined with clinical judgment, gastroscopy should be performed if necessary 10. Active ulcers, unhealed wounds or fractures; 11. Uncontrolled hypertension by antihypertensive medication (systolic blood pressure = 150mmHg or diastolic blood pressure = 100mmHg); 12. Urine routine indicated urinary protein =++ and confirmed 24-hour urinary protein volume >1.0g; 13. Any bleeding events with a severe grade reaching CTCAE 5.0 grade 2 or above occurred within 4 weeks before the first medication 14. Patients with active infection or unexplained fever of >38.5 °C during screening or prior to the first dose 15. Patients with congenital or acquired immunodeficiency (such as HIV infection), or active hepatitis (for hepatitis B: HBsAg positive and HBV DNA = 500 IU/mL for hepatitis C: HCV antibody positive and HCV copy number > ULN) 16. Patients who have previously received radiotherapy, chemotherapy, endocrine therapy, or molecular targeted therapy in less than 4 weeks prior to randomization after the end of such treatments (last dose) (or less than 5 half-lives for oral molecular targeted therapy) patients with adverse events from a previous treatment (except for alopecia) that have not returned to = Grade 1 (CTCAE 5.0) 17. Hyperactive/venous thrombosis events occurred within 6 months before the first medication, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. 18. Patients with hereditary or acquired bleeding history or coagulation disorders (such as hemophilia, coagul
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median overall survival;Time to First Subsequent Treatment;Objective Response Rate;Disease control rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactLi Sun
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed