Fluzoparib and Apatinib Versus Fluzoparib in Relapsed Ovarian Carcinoma Maintenance Treatment

Inclusion Criteria

• •1. The patient voluntarily joined the study and signed the informed consent
• •2. Patients ≥18 years of age.
• •3. Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; ≥grade II ovarian endometrioid adenocarcinoma.
• •* Mixed mullerian: contain high-grade serous component or endometrioid components over 50%.
• •4. Participant has received 2 or 3 previous lines of platinum-containing therapy and the last chemotherapy course contains platinum regimen.
• •* Preoperative neoadjuvant chemotherapy and postoperative chemotherapy were considered as 1 line chemotherapy treatment.
• •5. Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months (184 days) after completion of their last dose of platinum chemotherapy
• •6. Participant has responded to last the platinum regimen (complete or partial response), remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen.
• •* The last chemotherapy must be a platinum-based chemotherapy regimen.
• •* Patient must have received at least 4 cycles of treatment for the last platinum-based chemotherapy.
• •* A detectable lesion or CA-125 ≥2 ×ULN is required before the last platinum treatment
• •* The imaging results showed CR or PR during the last platinum-containing regimen. CA125 decreased to within the ULN or ≥90% from pre-treatment level during treatment and CA125 remained \<1xULN or did not increase by \>10% in 7 days before the first treatment.
• •* If no lesion is assessed prior to chemotherapy, CA125 should be alleviated to the ULN during treatment and maintained at \<1xULN for 7 days prior to the first treatment.
• •7. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to enrollment.
• •8. Participant had prior treatment with PARP inhibitor in a maintenance setting:
• •* For the BRCA1/2 cohort, the duration of first PARPi exposure must have been ≥18 months following a first line of chemotherapy or ≥12 months following a second line of chemotherapy.
• •* For the non BRCA1/2 cohort, the duration of first PARPi exposure must have been ≥12 months following a first line of chemotherapy or ≥6 months following a second line of chemotherapy.
• •9. Participant has adequate organ function as defined in the following contents (Any blood component or cell growth factor within 14 days prior to randomization is not permitted) Absolute neutrophil count (ANC) ≥1.5×109/L Platelets ≥100×109/L Hemoglobin ≥10g/dL Serum albumin ≥3g/dL Total bilirubin ≤1.5 ×ULN AST (SGOT) and ALT (SGPT) ≤3 × ULN Serum creatinine ≤1.5 × ULN
• •10. Patients with potential fertility need to use a medically approved contraceptive (such as an intrauterine device, birth control pill or condom) during and for 3 months after the study period; Serum HCG or urine HCG must be negative within 72 hours prior to study enrollment; must be a non-lactation period.