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
NCT07000344 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2026-04-09
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
Interventions
- 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.
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2026-03-29
- Completion
- 2026-03-30
Countries
- China
Study Locations
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