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)
FIGO stage III with non-R0 resection;
FIGO stage IV;
Presence of ascites at initial diagnosis.
Previous treatment with anti-angiogenic drugs such as apatinib, sorafenib, anlotinib, bevacizumab, or other anti-angiogenic therapies.
Pregnant or breastfeeding women.
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.
Single group
Paclitaxel
DrugFirst-line chemotherapy regimen: * Paclitaxel: 175 mg/m², intravenous infusion, on day 1. * Carboplatin: AUC 5, intravenous infusion, on day 1. * Surufatinib：250 mg once daily, taken continuously. Maintenance Therapy Regimen: * Surufatinib: 250 mg once daily, taken continuously. * Olaparib: 300 mg twice daily.
Progression free survival
Progression-free survival on first-line and maintenance therapy with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib
Overall Response Rate (ORR
ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions
Disease control rate
the percentage of patients with complete response, partial response, and stable disease for more than 4 weeks in which response can be evaluated
Overall survival
the date of enrollment to the date of death from any cause
Adverse event
Adverse medical events in clinical trial subjects treated with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib
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Anhui Provincial Cancer Hospital
Lead sponsor
Hutchison Medipharma Limited
Collaborator
