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

Korábbi kezelés

• Previous treatment with anti-angiogenic drugs such as apatinib, sorafenib, anlotinib, bevacizumab, or other anti-angiogenic therapies.
• Patients who have previously participated in other clinical trials that have not yet concluded.
• Patients with evidence or history of significant bleeding tendencies or events within 3 months before enrollment (bleeding >30 mL, accompanied by hematemesis, melena, or hematochezia), hemoptysis (≥5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months.
• Patients with any signs or history of bleeding disorders, regardless of severity; patients who experienced any bleeding or hemorrhagic event ≥CTCAE grade 3 within 4 weeks before enrollment; patients with unhealed wounds, ulcers, or fractures.

Más betegség

• Patients with uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
• Patients with active or uncontrolled severe infections (≥CTC AE grade 2).
• Patients with renal failure requiring hemodialysis or peritoneal dialysis.
• Patients with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation.
• Patients with psychiatric disorders, including epilepsy, dementia, severe depression, mania, etc.
• Patients who had arterial or venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, within the past 6 months.
• Patients with a history of substance abuse that cannot be relinquished or those with psychiatric disorders.
• Patients with difficulty swallowing or known absorption disorders affecting drug intake.
• Patients allergic to treatment drugs sorafenib or paclitaxel/carboplatin.
• Any other condition that the researcher deems unsuitable for enrollment.

Laborértékek

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

Egyéb

• Pregnant or breastfeeding women.
• Patients with persistent proteinuria (≥++) on two consecutive urine tests, and confirmed 24-hour urine protein >1.0 g.
• Patients with symptomatic brain metastases or those whose symptoms have been controlled for less than 2 months.

• Age: 18-75 years old (≥18, ≤75)
• Patients with newly diagnosed FIGO stage III or IV high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal cancer, and/or fallopian tube cancer with high-risk factors for recurrence. High-risk recurrence is defined as follows:
  • FIGO stage III with non-R0 resection;
  • FIGO stage IV;
  • Presence of ascites at initial diagnosis.
• Patients who have undergone primary debulking surgery (PDS) for ovarian cancer.
• ECOG performance status score: 0-2.
• Postoperative administration time ≤12 weeks.
• Expected survival of at least 3 months.
• 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;
  • Platelets (PLT) ≥100×10⁹/L.
• 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.
• Women of childbearing potential must use effective contraception.
• Subjects must voluntarily join the study and sign the informed consent form (ICF).
• Subjects are expected to have good compliance and the ability to follow up on efficacy and adverse reactions as required by the protocol.