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
Patients will have tests and exams to see if they are eligible for the clinical trial. First-line chemotherapy regimen: Paclitaxel/Carboplatin(repeat every 3 weeks, total of 6 cycles): * Paclitaxel: 175 mg/m², intravenous infusion, on day 1. * Carboplatin: AUC 5, intravenous infusion, on day 1. * For patients aged ≥70 years or those with comorbidities, the paclitaxel dose can be adjusted to 135 mg/m². Surufatinib(repeat every 3 weeks, total of 5 cycles): * Surufatinib is not used during the first postoperative cycle. * Starting from the second postoperative cycle, surufatinib is administered at a dose of 250 mg once daily, taken continuously. Maintenance Therapy Regimen: HRD-positive Patients: * Surufatinib: 250 mg once daily, taken continuously. * Olaparib: 300 mg twice daily, with doses taken 12 hours apart. Olaparib can be used for a maximum of 2 years. HRD-negative or HRD Status Unknown Patients: * Surufatinib: 250 mg once daily, taken continuously. Treatment continues until the patient experiences disease progression or meets other criteria for discontinuation of the study treatment as specified in the protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
First-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.
Anhui Cancer Hospital
Hefei, Anhui, China
RECRUITINGProgression free survival
Progression-free survival on first-line and maintenance therapy with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib
Time frame: 12-month
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
Time frame: 3-month
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
Time frame: 3-month
Overall survival
the date of enrollment to the date of death from any cause
Time frame: 3-years
Adverse event
Adverse medical events in clinical trial subjects treated with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib
Time frame: 3-month
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