NCT06954584

Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer

An Open-label, Randomized Controlled, Multicenter Study With Dual HRD-positive/Negative Cohorts Evaluating Fluzoparib Monotherapy Versus Combination Therapy With Bevacizumab or Dietary Intervention as Maintenance Treatment Following First-line Platinum-based Chemotherapy in Advanced Ovarian Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Fluzoparib has been approved for the first-line maintenance treatment of advanced ovarian cancer in the full population . Previous studies have demonstrated that anti-angiogenic agents enhance tumor cell sensitivity to PARP inhibitors . In vitro evidence suggests that low-carbohydrate culture conditions may restore PARP inhibitor sensitivity in HRD-negative tumor cells. This study aims to validate the survival benefits of fluzoparib combined with bevacizumab in HRD-positive ovarian cancer patients during first-line maintenance therapy and explore the efficacy of fluzoparib combined with a dietary intervention in HRD-negative populations.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab : 15 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 15 months
DRUG	Fluzoparib Monotherapy	150 mg orally bid (50 mg/capsule, 3 capsules/dose)
BEHAVIORAL	Dietary Intervention	Control carbohydrate intake in the daily diet

Timeline

• Start date: 2025-05-27
• Primary completion: 2030-05-01
• Completion: 2032-03-01
• First posted: 2025-05-01
• Last updated: 2025-06-24

Locations

2 sites across 1 country: China