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RECRUITING
NCT06954584
PHASE3

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

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

424

Start Date

2025-05-27

Completion Date

2032-03-01

Last Updated

2025-06-24

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (2)

Tongji Hospital

Wuhan, Hubei, China

Tongji Hospital

Wuhan, Hubei, China