Fluzoparib Plus Famitinib Maintenance After First-Line Platinum Response in Advanced Ovarian Cancer

Summary

This is a single-arm, open-label, multicenter exploratory clinical study designed to evaluate the efficacy and safety of fluzoparib combined with famitinib malate as maintenance therapy in patients with newly diagnosed advanced (FIGO III-IV) high-grade serous or endometrioid ovarian cancer (including fallopian tube and primary peritoneal cancer) who have achieved a complete response (CR) or partial response (PR) after first-line platinum-based chemotherapy (with or without bevacizumab). Eligible women aged 18-75 years with ECOG 0-1 will start study treatment within \<9 weeks after the last platinum dose. Participants will receive fluzoparib 150 mg orally twice daily plus famitinib malate 10 mg orally once daily in 28-day cycles, continuing for up to 24 cycles or until disease progression, unacceptable toxicity, initiation of new anti-tumor therapy, withdrawal of consent, or investigator decision. The primary endpoint is progression-free survival (PFS); secondary endpoints include overall survival (OS), duration of response (DOR), time to response (TTR), and PFS-2.

Timeline

Start

2026-02-28

Primary completion

2030-12-31

Completion

2030-12-31

Drugs

Indications