Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer
- Conditions
- Ovarian Cancer
- Registration Number
- NCT06437353
- Lead Sponsor
- Anhui Provincial Cancer Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 74
Inclusion Criteria:<br><br> 1. Age: 18-75 years old (=18, =75)<br><br> 2. Patients with newly diagnosed FIGO stage III or IV high-grade serous ovarian cancer,<br> high-grade endometrioid carcinoma, primary peritoneal cancer, and/or fallopian tube<br> cancer with high-risk factors for recurrence. High-risk recurrence is defined as<br> follows:<br><br> - FIGO stage III with non-R0 resection;<br><br> - FIGO stage IV;<br><br> - Presence of ascites at initial diagnosis.<br><br> 3. Patients who have undergone primary debulking surgery (PDS) for ovarian cancer.<br><br> 4. ECOG performance status score: 0-2.<br><br> 5. Postoperative administration time =12 weeks.<br><br> 6. Expected survival of at least 3 months.<br><br> 7. Major organ function within 7 days prior to treatment meets the following criteria:<br><br> - Hemoglobin (HB) =90 g/L;<br><br> - Absolute neutrophil count (ANC) =1.5×10?/L;<br><br> - Platelets (PLT) =100×10?/L.<br><br> 8. Biochemical parameters must meet the following standards:<br><br> - Total bilirubin (TBIL) =1.5 times the upper limit of normal (ULN);<br><br> - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN,<br> or =5×ULN if liver metastases are present;<br><br> - Serum creatinine (Cr) =1.5×ULN or creatinine clearance (CCr) =60 ml/min.<br><br> 9. Women of childbearing potential must use effective contraception.<br><br> 10. Subjects must voluntarily join the study and sign the informed consent form (ICF).<br><br> 11. Subjects are expected to have good compliance and the ability to follow up on<br> efficacy and adverse reactions as required by the protocol.<br><br>Exclusion Criteria:<br><br> 1. Previous treatment with anti-angiogenic drugs such as apatinib, sorafenib,<br> anlotinib, bevacizumab, or other anti-angiogenic therapies.<br><br> 2. Pregnant or breastfeeding women.<br><br> 3. Patients who have previously participated in other clinical trials that have not yet<br> concluded.<br><br> 4. Patients with evidence or history of significant bleeding tendencies or events<br> within 3 months before enrollment (bleeding >30 mL, accompanied by hematemesis,<br> melena, or hematochezia), hemoptysis (=5 mL of fresh blood within 4 weeks), or<br> thromboembolic events (including stroke and/or transient ischemic attack) within 12<br> months.<br><br> 5. Patients with uncontrolled hypertension (systolic blood pressure =150 mmHg or<br> diastolic blood pressure =100 mmHg).<br><br> 6. Patients with grade I or higher myocardial ischemia or infarction, arrhythmias<br> (including QTc =480 ms), or = grade 2 congestive heart failure (New York Heart<br> Association (NYHA) classification).<br><br> 7. Patients with active or uncontrolled severe infections (=CTC AE grade 2).<br><br> 8. Patients with renal failure requiring hemodialysis or peritoneal dialysis.<br><br> 9. Patients with a history of immunodeficiency, including HIV positivity or other<br> acquired or congenital immunodeficiency diseases, or those with a history of organ<br> transplantation.<br><br> 10. Patients with persistent proteinuria (=++) on two consecutive urine tests, and<br> confirmed 24-hour urine protein >1.0 g.<br><br> 11. Patients with psychiatric disorders, including epilepsy, dementia, severe<br> depression, mania, etc.<br><br> 12. Patients with any signs or history of bleeding disorders, regardless of severity;<br> patients who experienced any bleeding or hemorrhagic event =CTCAE grade 3 within 4<br> weeks before enrollment; patients with unhealed wounds, ulcers, or fractures.<br><br> 13. Patients who had arterial or venous thrombotic events, such as cerebrovascular<br> accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary<br> embolism, within the past 6 months.<br><br> 14. Patients with symptomatic brain metastases or those whose symptoms have been<br> controlled for less than 2 months.<br><br> 15. Patients with a history of substance abuse that cannot be relinquished or those with<br> psychiatric disorders.<br><br> 16. Patients with difficulty swallowing or known absorption disorders affecting drug<br> intake.<br><br> 17. Patients allergic to treatment drugs sorafenib or paclitaxel/carboplatin.<br><br> 18. Any other condition that the researcher deems unsuitable for enrollment.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR;Disease control rate;Overall survival;Adverse event