Fluzoparib Neoadjuvant Therapy for Ovarian Cancer

Inclusion Criteria:

1. Female patients aged 18-75 years.

2. Biopsies obtained via open surgery, laparoscopic surgery, or needle biopsy,confirmed by professional pathologists as high-grade serous or endometrioid ovariancancer, peritoneal cancer, or fallopian tube cancer (hereinafter referred to asovarian cancer); FIGO stage III-IV.

3. Presence of BRCA1/2 mutation or HRD positivity confirmed in tissue or blood samplesby the designated testing institution of the study center.

4. Before any trial procedures begin, an informed consent form must be signed accordingto the principle of informed consent and filed at the study center.

5. The patient must have at least one measurable lesion that can be assessed by CT orMRI (RECIST 1.1).

6. Blood and tissue samples from patients can be obtained before, during, and aftertreatment, and subjects agree to submit blood and tissue samples to the centrallaboratory for the purpose of expansion research for this trial, including but notlimited to: (1) possible gene-related research; (2) Possible tumor marker-relatedresearch.

7. Patients deemed unable to achieve R0 cytoreduction or unable to tolerate surgery bygynecologic oncologists at the study center: (1) Fagotti laparoscopic score ≥ 8points; (2) When laparoscopic assessment is difficult to perform, an upper abdominalCT score ≥ 3 points may be used. Criteria for determining inability to toleratesurgery may include: (1) BMI ≥ 40.0; (2) Multiple chronic diseases; (3) Malnutritionor hypoproteinemia; (4) Moderate to large amounts of ascites; (5) Newly diagnosedvenous thromboembolism; (6) ECOG > 2.

8. Expected survival time > 12 weeks.

9. Patients with an ECOG score of 0-2.

10. Good organ function. (1) Bone marrow function: NEUT ≥ 1.510^9/L; PLT ≥ 10010^9/L;HGB ≥ 100g/L. (2) Liver function: TBIL ≤ 1.5 times the upper limit of normal or DBIL ≤ 1.0 times the upper limit of normal; AST and ALT ≤ 2.5 times the upper limit ofnormal, and in the presence of liver metastasis, must be ≤ 5 times the upper limitof normal. (3) Renal function: serum creatinine ≤ 1.5 times the upper limit ofnormal, or creatinine clearance rate ≥ 60 mL/min (calculated using theCockcroft-Gault formula).

11. For women of reproductive age, a negative blood or urine pregnancy test within oneweek prior to enrollment is required, and effective contraceptive measures must betaken after enrollment, such as using physical barrier methods (condoms) or completeabstinence. The use of oral, injectable, or implantable hormonal contraceptives isnot permitted. Or women who are not of reproductive age, defined as those who havenaturally entered menopause and have been amenorrheic for over a year, haveundergone surgical sterilization (bilateral oophorectomy, bilateral salpingectomy,or hysterectomy), or have serum follicle-stimulating hormone, luteinizing hormone,and plasma estradiol levels within the menopausal range as specified by the studycenter laboratory.

12. Understand the trial process and voluntarily sign the informed consent form, withthe ability to comply with the trial protocol for the duration of the study,including cooperating with any required treatments, examinations, tests, follow-ups,and questionnaires.

13. Patients are willing to complete quality of life questionnaires during the trialtreatment and follow-up process, and agree that the results of these questionnairesmay be used for clinical research.

14. Any prior chemotherapy-related toxicities must have resolved to ≤ CTCAE grade 1 orbaseline levels, except for stable grade 2 or lower sensory neuropathy or alopecia.

Exclusion Criteria:

1. Concurrent use of other investigational drugs or participation in other clinicaldrug trials during this study.

2. Concurrent use of other neoadjuvant treatments for cancer during this study,including but not limited to chemotherapy, radiotherapy, immunotherapy, microbialtherapy, traditional Chinese medicine, and other experimental therapies.

3. Known allergy to Fluzoparib or any active or inactive components with a similarchemical structure to Fluzoparib.

4. Unable to swallow oral medications, and having any gastrointestinal disorders thatmay interfere with the absorption or metabolism of the study drug, such asuncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption.

5. Received any cancer-related treatment for ovarian cancer.

6. Previously received known or potential PARP inhibitor therapy.

7. Symptomatic or uncontrollable brain metastases requiring concurrent treatment,including but not limited to surgery, radiation, and/or corticosteroids, or clinicalmanifestations of spinal cord compression.

8. History of severe venous thrombosis or pulmonary embolism.

9. Received other molecular targeted therapy within 4 weeks before enrollment.

10. Symptomatic or uncontrollable brain metastases requiring concurrent treatment,including but not limited to surgery, radiation, and/or corticosteroids, or clinicalmanifestations of spinal cord compression.

11. Undergone major surgery within 3 weeks before the start of the study, or not yetrecovered from surgery.

12. Presence of uncorrected electrolyte disturbances at the time of dosing.

13. Subjects have had other malignant diseases in the past 3 years, except foreffectively treated skin squamous cell carcinoma, basal cell carcinoma, ductalcarcinoma in situ of the breast, or cervical carcinoma in situ.

14. Patients have a history of or current diagnosis of myelodysplastic syndrome (MDS) oracute myeloid leukemia (AML).

15. Patients with severe, uncontrolled diseases or whom the investigator judges to begenerally unsuitable for inclusion in the study, including but not limited to:active viral infections such as human immunodeficiency virus, hepatitis B, hepatitisC, etc.; severe cardiovascular diseases, uncontrolled ventricular arrhythmias,myocardial infarction within the last 3 months; uncontrolled grand mal seizures,unstable spinal cord compression, superior vena cava syndrome, or other mentaldisorders that may affect the patient's ability to sign the informed consent;uncontrolled hypertension; immunodeficiency (excluding splenectomy) or otherconditions that the investigator considers may expose the patient to high-risktoxicity.

16. Any medical history or existing clinical evidence suggesting potential confoundingof study results, interference with patient compliance with the study protocolthroughout the study treatment period, or not in the best interest of the patient.

17. The patient received a platelet or red blood cell transfusion within 3 days beforethe start of treatment with the study drug.

18. Pregnant or lactating patients, or those planning to become pregnant during thestudy treatment period.

19. Clinically unresolved prior treatment toxicity (≥ grade 2), excluding alopecia,neuropathy, lymphocytopenia, and skin hypopigmentation.

20. Persons involved in the planning or implementation of the study.