NCT07355010

A Randomized, Open-label, Double-cohort Study of Fluzoparib Combined With Famitinib Malate or SHR-1701 for Neoadjuvant Therapy in Patients With Advanced Ovarian Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Qinglei Gao · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, open-label, double-cohort, national multi-center clinical research. The aim is to evaluate the newly diagnosed FIGO 2014 stage III-IV pathology of neoadjuvant therapy with fluzoparib combined with famitinib or fluzoparib combined with SHR-1701, based on the Fagotti laparoscopy score or upper abdominal Suidan's by the researchers The CT score assesses the efficacy and safety of patients with germline BRCA wild-type ovarian cancer who cannot achieve R0 resection or cannot tolerate initial cytoreductive surgery, as well as the efficacy and safety of surgery, adjuvant therapy, and combined maintenance treatment regimens based on fluzoparib. The primary endpoint was the objective response rate (ORR) after neoadjuvant therapy as assessed by the researchers based on the RECIST v1.1 criteria. Meanwhile, the chemotherapy response score (CRS), event-free survival (EFS), disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) were also examined. The safety, tolerability and patient-reported outcomes (EQ-5D-5L) of the two cohorts were investigated. A total of 104 newly diagnosed epithelial ovarian cancer patients with germline BRCA wild-type (FIGO 2014 stage III-IV) are planned to be enrolled.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	fuzuloparib	fuzuloparib 150mg bid PO
DRUG	Famitinib	famitinib 10mg qd PO
DRUG	SHR-1701	SHR-1701 1800 mg IV Q3W

Timeline

• Start date: 2025-12-30
• Primary completion: 2028-12-30
• Completion: 2030-12-30
• First posted: 2026-01-21
• Last updated: 2026-01-21