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

Ovarian Cancer Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

• NCT number: NCT06437353
• Study type: Interventional
• Source: Anhui Provincial Cancer Hospital
• Contact: Bai-Rong Xia, Doctor
• Phone: 18604516165
• Email: xiabairong9999@126.com
• Status: Recruiting
• Phase: Phase 2
• Start date: May 25, 2024
• Completion date: October 30, 2027