A Prospective, Single-Arm, Single-Center, Phase II Clinical Trial Evaluating the Efficacy and Safety of Fluzoparib Combined With QL1101 for Maintenance Treatment in Patients With Advanced Epithelial Ovarian Cancer Following Response After First-line Platinum-containing Chemotherapy
This is a Prospective,Single-Center, Single-Arm, Phase 2 study to evaluate the efficacy and safety of Fluzoparib Combined With QL1101, as maintenance treatment, in patients with Advanced FIGO Stage III or IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or primary peritoneal cancer following front-line platinum-based chemotherapy with QL1101. Eligible participants who achieve complete response (CR) or partial response (PR) following treatment with platinum-based chemotherapy in addition to QL1101 will be enrolled in the study and will receive maintenance treatment with fluzoparib (for up to 2 years) combined with QL1101 (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first.
⁃ I-1.Patients voluntarily participated in this study and signed the informed consent.
⁃ I-2.Age 18-70 years, female. I-3.Eastern Cooperative Oncology Group (ECOG) performance status 0-1. I-4.Patients with newly diagnosed, histologically confirmed, high grade serous or high grade endometrioid ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer（FIGO Stage III or IV）.
⁃ I-5.Completion of ideal tumor cytoreduction (either intermediate cytoreduction or initial cytoreduction).
⁃ I-6.First line therapy with platinum-taxane chemotherapy consists of a minimum of 6 treatment cycles and a maximum of 8 treatment cycles in patients who have achieved complete response (CR) or partial response (PR).
⁃ I-7.Patients who must receive at least 4 cycles of platinum-based therapy if non-hematologic toxicity specifically associated with platinum-based therapy (i.e., neurotoxicity, hypersensitivity reactions, etc.) necessitates early termination.
⁃ I-8.Those who can swallow tablets normally.
⁃ I-9.The functions of vital organs meet the following requirements:
• Absolute neutrophil count ≥ 1.5 × 109/L;
• Platelets ≥ 90 × 109/L;
• Hemoglobin ≥ 100 g/L;
• Serum albumin ≥ 30 g/L;
• Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN);
• ALT and AST ≤ 3 × ULN; in case of liver metastases, ALT and AST \< 5 × ULN;
• Serum creatinine ≤ 1.5 × ULN;
• International normalized ratio (INR) ≤1.5 and activated prothrombin time (aptt) ≤1.5× ULN in patients not receiving anticoagulants.
⁃ I-10.Maintenance therapy is initiated within 8 weeks, counting from the last day of the last chemotherapy session, and all major toxicities from prior chemotherapy must be resolved by maintenance therapy to CTC Adverse Event grade 1 or better (except alopecia and peripheral neuropathy).
⁃ I-11.Normal blood pressure or adequately treated and controlled hypertension (systolic blood pressure ≤ 140 mmHg and/or diastolic blood pressure ≤ 90 mmHg) .
⁃ I-12.Willingness to undergo genetic testing: including germline and/or systemic BRCA1/2 testing, HRD testing, etc.
⁃ I-13.Non-surgical sterilization or female patients of childbearing age need to use two medically approved contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study treatment period and within 3 months after the end of the study treatment period; non-surgical sterilized female patients of childbearing age must have a negative serum human chorionic gonadotropin(HCG) test within 72 hours before the first dose, and must be non-lactating; for male patients whose partners are women of childbearing age, two effective methods of contraception should be used during the study treatment period and for 3 months after the end of the study treatment period.