A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Inclusion Criteria: 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) performancestatus 0-1. I-4.Patients with newly diagnosed, histologically confirmed, high grade serousor high grade endometrioid ovarian cancer, fallopian-tube cancer, or primary peritonealcancer（FIGO Stage III or IV）. I-5.Completion of ideal tumor cytoreduction (either intermediate cytoreduction or initialcytoreduction). I-6.First line therapy with platinum-taxane chemotherapy consists of a minimum of 6treatment cycles and a maximum of 8 treatment cycles in patients who have achieved completeresponse (CR) or partial response (PR). I-7.Patients who must receive at least 4 cycles of platinum-based therapy ifnon-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:

1. Absolute neutrophil count ≥ 1.5 × 109/L;
2. Platelets ≥ 90 × 109/L;
3. Hemoglobin ≥ 100 g/L;
4. Serum albumin ≥ 30 g/L;
5. Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN);
6. ALT and AST ≤ 3 × ULN; in case of liver metastases, ALT and AST < 5 × ULN;
7. Serum creatinine ≤ 1.5 × ULN;
8. 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 thelast chemotherapy session, and all major toxicities from prior chemotherapy must beresolved by maintenance therapy to CTC Adverse Event grade 1 or better (except alopecia andperipheral neuropathy). I-11.Normal blood pressure or adequately treated and controlled hypertension (systolicblood pressure ≤ 140 mmHg and/or diastolic blood pressure ≤ 90 mmHg) . I-12.Willingness to undergo genetic testing: including germline and/or systemic BRCA1/2testing, HRD testing, etc. I-13.Non-surgical sterilization or female patients of childbearing age need to use twomedically approved contraceptive measures (such as intrauterine devices, contraceptives orcondoms) during the study treatment period and within 3 months after the end of the studytreatment period; non-surgical sterilized female patients of childbearing age must have anegative serum human chorionic gonadotropin(HCG) test within 72 hours before the firstdose, and must be non-lactating; for male patients whose partners are women of childbearingage, two effective methods of contraception should be used during the study treatmentperiod and for 3 months after the end of the study treatment period.

Exclusion Criteria: E-1.Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germcell tumors). E-2.Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinouscarcinoma. E-3.Clinical evidence of stable disease or progressive disease following treatment at theend of the first-line chemotherapy. E-4.Other malignancy within the last 5 years except: adequately treated non-melanoma skincancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS)Patients with a history of localized malignancy diagnosed over 5 years ago, who havecompleted all treatment and have no recurrent or metastatic disease prior to enrollment maybe enrolled. E-5.Patients with myelodysplastic syndrome/acute myeloid leukemia history. E-6.Patientsreceiving radiotherapy within 6 weeks or Major surgery within 4 weeks prior to studytreatment. E-7.Any previous treatment with PARP inhibitor, including fluzoparib. E-8.Prior history ofhypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy. E-9.Clinically significant (e.g. active) cardiovascular disease, including:

1. New York Heart Association (NYHA) grade 2 or higher heart failure.
2. Unstable angina pectoris.
3. Myocardial infarction within 1 year.
4. Clinically significant supraventricular or ventricular arrhythmia requiring treatmentor intervention.
5. Qtc>470ms. E-10.Patients who underwent cytoreductive surgery more than once beforemaintenance treatment（Patients who were considered unresectable at diagnosis onlyreceived biopsy or ovarian resection, and then continued chemotherapy for intermediatecytoreductive surgery may be enrolled）. E-11.Patients who have received chemotherapy for abdominal or pelvic tumors, includingthose who received chemotherapy for early diagnosis of ovarian cancer, fallopian tubecancer, or primary peritoneal cancer. E-12.Patients with synchronous primary endometrial cancer unless both of the following twocriteria are met:
6. Sage < 2.
7. Less than 60 years old at the time of diagnosis of endometrial cancer with stage ia orib grade 1 or 2, or stage ia grade 3 endometrioid adenocarcinoma or ≥ 60 years old atthe time of diagnosis of endometrial cancer with stage ia grade 1 or 2 endometrioidadenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma ofthe endometrium are not eligible. E-13.Pregnant or lactating women. E-14.Concomitant use of known potent CYP3A4 inhibitorssuch as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin,clarithromycin, and nelfinavir. E-15.History of allergic reactions to carboplatin. E-16.Participation in another clinicalstudy with an investigational product.