Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer

Inclusion Criteria:

1. Age: 18-75 years old (≥18, ≤75)

2. Patients with newly diagnosed FIGO stage III or IV high-grade serous ovarian cancer,high-grade endometrioid carcinoma, primary peritoneal cancer, and/or fallopian tubecancer with high-risk factors for recurrence. High-risk recurrence is defined asfollows:

• FIGO stage III with non-R0 resection;

• FIGO stage IV;

• Presence of ascites at initial diagnosis.

3. Patients who have undergone primary debulking surgery (PDS) for ovarian cancer.

4. ECOG performance status score: 0-2.

5. Postoperative administration time ≤12 weeks.

6. Expected survival of at least 3 months.

7. Major organ function within 7 days prior to treatment meets the following criteria:

• Hemoglobin (HB) ≥90 g/L;

• Absolute neutrophil count (ANC) ≥1.5×10⁹/L;

≥100×10⁹/L.

8. Biochemical parameters must meet the following standards:

• Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN,or ≤5×ULN if liver metastases are present;

• Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60 ml/min.

9. Women of childbearing potential must use effective contraception.

10. Subjects must voluntarily join the study and sign the informed consent form (ICF).

11. Subjects are expected to have good compliance and the ability to follow up onefficacy and adverse reactions as required by the protocol.

Exclusion Criteria:

1. Previous treatment with anti-angiogenic drugs such as apatinib, sorafenib,anlotinib, bevacizumab, or other anti-angiogenic therapies.

2. Pregnant or breastfeeding women.

3. Patients who have previously participated in other clinical trials that have not yetconcluded.

4. Patients with evidence or history of significant bleeding tendencies or eventswithin 3 months before enrollment (bleeding >30 mL, accompanied by hematemesis,melena, or hematochezia), hemoptysis (≥5 mL of fresh blood within 4 weeks), orthromboembolic events (including stroke and/or transient ischemic attack) within 12months.

5. Patients with uncontrolled hypertension (systolic blood pressure ≥150 mmHg ordiastolic blood pressure ≥100 mmHg).

6. Patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc ≥480 ms), or ≥ grade 2 congestive heart failure (New York HeartAssociation (NYHA) classification).

7. Patients with active or uncontrolled severe infections (≥CTC AE grade 2).

8. Patients with renal failure requiring hemodialysis or peritoneal dialysis.

9. Patients with a history of immunodeficiency, including HIV positivity or otheracquired or congenital immunodeficiency diseases, or those with a history of organtransplantation.

10. Patients with persistent proteinuria (≥++) on two consecutive urine tests, andconfirmed 24-hour urine protein >1.0 g.

11. Patients with psychiatric disorders, including epilepsy, dementia, severedepression, mania, etc.

12. Patients with any signs or history of bleeding disorders, regardless of severity;patients who experienced any bleeding or hemorrhagic event ≥CTCAE grade 3 within 4weeks before enrollment; patients with unhealed wounds, ulcers, or fractures.

13. Patients who had arterial or venous thrombotic events, such as cerebrovascularaccidents (including transient ischemic attacks), deep vein thrombosis, or pulmonaryembolism, within the past 6 months.

14. Patients with symptomatic brain metastases or those whose symptoms have beencontrolled for less than 2 months.

15. Patients with a history of substance abuse that cannot be relinquished or those withpsychiatric disorders.

16. Patients with difficulty swallowing or known absorption disorders affecting drugintake.

17. Patients allergic to treatment drugs sorafenib or paclitaxel/carboplatin.

18. Any other condition that the researcher deems unsuitable for enrollment.