First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer

Exclusion Criteria

• •1. Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer with no recurrence \>3 years after radical surgery;
• •2. Patients with untreated central nervous system metastases:
• •-Patients with prior treatment (radiotherapy or surgery) for systemic, radical brain or meningeal metastases may be enrolled if imaging confirms that stabilization has been maintained for at least 1 month and systemic hormone therapy (dose \>10mg/day prednisone or other equivocal hormone) has been discontinued for more than 2 weeks and who have no clinical evidence can be included;
• •3. Any previous treatment with PARP inhibitor, including, olaparib, niraparib, rucaparib, pamiparib, and fluzoparib;
• •4. Inability to swallow tablets properly or gastrointestinal function, may interfere with drug absorption, according to the investigator.
• •5. Recent (within 3 months) occurrence of intestinal obstruction, gastrointestinal perforation;
• •6. Patients with clinically symptomatic carcinomatous ascites or pleural effusion who need puncture or drainage or who have received drainage of ascites or pleural effusion within 2 months prior to the first trial of drug administration.
• •7. Patients with clinically significant cardiovascular disease that are not well controlled, such as (1) New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF) (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) QTc \> 470ms;
• •8. Patients with abnormal coagulation (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds), bleeding tendency, or who are receiving thrombolytic or anticoagulant therapy are permitted to receive low-dose low molecular heparin or oral aspirin for prophylactic anticoagulation during the trial;
• •9. Patients who have experienced clinically significant bleeding symptoms or have a definite bleeding tendency within 3 months prior to the first dose, such as peptic bleeding, bleeding gastric ulcer, or suffering from vasculitis, etc., may be retested if the fecal occult blood is positive at the baseline period, and if it is still positive after the retesting, combined with the clinical judgment, and if necessary, gastroscopy will be carried out;
• •10. Accompanied by active ulcers, unhealed wounds or with fractures;
• •11. Patients who suffering from hypertension which cannot be well controlled by antihypertensive medication (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 90mmHg);
• •12. Any bleeding event with a severity rating of 2 or more on the CTCAE 5.0 within 4 weeks prior to the first dose;
• •13. Patients has an active infection or an unexplained fever \>38.5 degrees during the screening period, prior to the first dose;
• •14. Patients who has a congenital or acquired immune deficiency (e.g., HIV-infected), or active hepatitis (Hepatitis B reference: HBsAg-positive, HBV DNA ≥500 IU/ml; Hepatitis C reference: HCV antibody-positive, HCV viral copy number \> upper limit of normal);
• •15. Prior history of radiotherapy, chemotherapy, hormonal therapy, or molecularly targeted therapy less than 4 weeks after completion of therapy (last dose) and prior to study drug administration (less than 5 drug half-lives for oral molecularly targeted agents); prior treatment-induced adverse events (other than alopecia) have not recovered to ≤ 1 degree (CTCAE 5.0);
• •16. Arterial/venous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to the first dose of medication.
• •17. Patients with an inherited or acquired history of bleeding or coagulation disorders (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.). There were clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, etc., within 3 months prior to the first dose;
• •18. Patients has received other systemic antitumor therapy during the study period;
• •19. In the investigator's judgment, patients have other factors that may lead to the forced termination of the study, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the subject's safety, or the collection of information and samples.