NCT06437353

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Anhui Provincial Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	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.

Timeline

• Start date: 2024-05-25
• Primary completion: 2025-10-30
• Completion: 2027-10-30
• First posted: 2024-05-31
• Last updated: 2024-11-27

Locations

1 site across 1 country: China