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

Launched by ANHUI PROVINCIAL CANCER HOSPITAL · May 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two different treatment plans for women with newly diagnosed high-risk ovarian cancer. The goal is to see how safe and effective Surufatinib is when used with either Carboplatin/Paclitaxel or Olaparib. These treatments are being tested as both initial therapy and for ongoing maintenance after the first treatment. The trial is currently looking for women aged 18 to 75 who have specific types of ovarian cancer that are considered high risk for recurrence and who have had surgery to remove the tumor.

To participate in the trial, women must meet certain criteria, such as having recently been diagnosed with advanced ovarian cancer and having good overall health, as measured by a performance scale. Participants can expect to receive the study treatments and will be monitored closely for their health and any side effects. It's important for potential participants to know that they cannot have had prior treatments with certain cancer drugs or have specific health issues that could complicate their participation. This trial aims to find better treatment options for women facing this challenging diagnosis.

Gender

FEMALE

Eligibility criteria

• 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 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.
• • 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;
• • Platelets (PLT) ≥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 on efficacy 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 yet concluded.
• • 4. 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.
• • 5. Patients with uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic 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 Heart Association (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 other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation.
• • 10. Patients with persistent proteinuria (≥++) on two consecutive urine tests, and confirmed 24-hour urine protein \>1.0 g.
• • 11. Patients with psychiatric disorders, including epilepsy, dementia, severe depression, 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 4 weeks before enrollment; patients with unhealed wounds, ulcers, or fractures.
• • 13. 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.
• • 14. Patients with symptomatic brain metastases or those whose symptoms have been controlled for less than 2 months.
• • 15. Patients with a history of substance abuse that cannot be relinquished or those with psychiatric disorders.
• • 16. Patients with difficulty swallowing or known absorption disorders affecting drug intake.
• • 17. Patients allergic to treatment drugs sorafenib or paclitaxel/carboplatin.
• • 18. Any other condition that the researcher deems unsuitable for enrollment.

Trial Officials