Combining Surufatinib with Chemotherapy for High-risk Ovarian Cancer

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

This study is testing if a new drug called Surufatinib, when combined with standard chemotherapy and another medication, can help people with newly diagnosed high-risk ovarian cancer live longer and feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Anhui Provincial Cancer Hospital (other)
• Drugs / interventions: bevacizumab, apatinib, anlotinib, Surufatinib, chemotherapy
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06437353 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Surufatinib in combination with Carboplatin/Paclitaxel and Olaparib as first-line and maintenance therapy for patients with newly diagnosed high-risk ovarian cancer. Participants will receive a specific chemotherapy regimen followed by maintenance therapy based on their HRD status. The study aims to determine the effectiveness of these combinations in improving patient outcomes and prolonging survival. Patients will undergo eligibility assessments to ensure they meet the criteria for participation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with newly diagnosed high-grade serous ovarian cancer or related conditions and high-risk factors for recurrence.

Not a fit: Patients with low-grade ovarian cancer or those who have not undergone primary debulking surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve survival rates and quality of life for patients with high-risk ovarian cancer.

How similar studies have performed: Other studies have shown promise with similar combinations of targeted therapies and chemotherapy in treating ovarian cancer, indicating potential for success in this approach.

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.

Where this trial is running

Hefei, Anhui

• Anhui Cancer Hospital — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Bairong Xia, Doctor

Conditions: Ovarian Cancer, Antiangiogenic