NCT06188455

Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer

Clinical Study of Fluzopalil Combined With Apatinib for Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Thirty-seven women aged 18-75 years with recurrent ovarian cancer were enrolled

Detailed description

The subjects selected surgery according to the actual situation, and received chemotherapy containing platinum after surgery, totaling 4 cycles of chemotherapy. After the completion of the treatment course, the researchers will use fluzoparil combined with apatinib to maintain the treatment until the disease progression in patients with CR, PR and SD evaluated according to RECIST 1.1 efficacy. The medication regimen for all enrolled patients was recommended as follows, and the dose could be adjusted during treatment due to adverse reactions and other circumstances: Fluzopalil capsules: Oral administration of 100 mg, 2 capsules/time (50 mg/capsule), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take oral administration in the morning and late 0.5h, continuous administration. Every 4 weeks is a treatment period. Apatinib tablets: Oral administration of 250 mg each time, 1 tablet/time (250 mg/tablet), it is recommended to take orally 0.5 h after breakfast, continuous administration. Every 4 weeks is a treatment period. Treatment will continue until an event occurs that meets the criteria for treatment termination.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Fluzoparib Capsules	Oral administration of 100 mg, 2 capsules/time (50 mg/capsule), twice daily
DRUG	Apatinib Mesylate Tablets	Oral administration of 250 mg each time, 1 tablet/time (250 mg/tablet)

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-01-03
• Last updated: 2024-01-03