NCT07000344

A Study of Apatinib Combined With Letrozole With or Without Fluzoparib in Estrogen Receptor-Positive, Platinum-Sensitive Recurrent Ovarian Cancer Previously Treated With First-Line PARP Inhibitor

A Multicenter, Open-Label, Prospective Cohort Study of Apatinib Plus Letrozole With or Without Fluzoparib as Second-Line Maintenance Therapy in ER-Positive, Platinum-Sensitive Recurrent Ovarian Cancer Following First-Line PARP Inhibitor Maintenance

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, open-label, prospective cohort clinical study enrolled 70 patients with late-stage ER（+）platinum-sensitive recurrent ovarian cancer who had achieved CR/PR after first-line PARP inhibitor maintenance therapy. The study was divided into two cohorts, with 35 participants in each. Cohort 1 (triple-drug group) received the following treatments: Apatinib: 250 mg orally once daily, with a 28-day treatment cycle. Fluzoparib: 100 mg orally twice daily, with a 4-week continuous treatment cycle. Letrozole: 2.5 mg orally once daily, with a 4-week continuous treatment cycle. Cohort 2 (dual-drug group) received: Apatinib: 250 mg orally once daily, with a 28-day treatment cycle. Letrozole: 2.5 mg orally once daily, with a 4-week continuous treatment cycle. reatment continued until disease progression, intolerable toxicity, or other protocol-specified reasons occurred.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Cohort 1 (triple-drug group)	Apatinib: 250 mg orally once daily, with a 28-day treatment cycle. Fluzoparib: 100 mg orally twice daily, with a 4-week continuous treatment cycle. Letrozole: 2.5 mg orally once daily, with a 4-week continuous treatment cycle. Treatment continued until disease progression, intolerable toxicity, or other protocol-specified reasons occurred.
DRUG	Cohort 2 (dual-drug group)	Apatinib: 250 mg orally once daily, with a 28-day treatment cycle. Letrozole: 2.5 mg orally once daily, with a 4-week continuous treatment cycle. Treatment continued until disease progression, intolerable toxicity, or other protocol-specified reasons occurred.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-03-29
• Completion: 2026-03-30
• First posted: 2025-06-02
• Last updated: 2026-04-09

Locations

1 site across 1 country: China