Sorafenib Combined With Carboplatin/Paclitaxel and Sorafenib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer: a Single-arm, Multicenter, Exploratory Clinical Study
The goal of this type of clinical trial study is to evaluate the safety and efficacy of Surufatinib combined with Carboplatin/Paclitaxel and Surufatinib combined with Olaparib as first-line and maintenance therapy for newly diagnosed high-risk ovarian cancer
• 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.