RecruitingPhase 3NCT06954584

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

Sponsor

Tongji Hospital

Enrollment

424 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a special diet or a blood-vessel-blocking drug (bevacizumab) to a targeted maintenance drug (fluzoparib, a PARP inhibitor) improves outcomes for women with advanced ovarian, fallopian tube, or peritoneal cancer after completing initial platinum-based chemotherapy. Maintenance therapy is given after the main treatment to help prevent the cancer from coming back. **You may be eligible if...** - You are a woman aged 18 or older with confirmed high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer (stage III or IV) - Your cancer has a specific DNA repair deficiency called HRD (homologous recombination deficiency) - You responded well to (or had no evidence of disease after) platinum-based chemotherapy - You are ready to begin maintenance therapy within 8 weeks of your last chemotherapy dose **You may NOT be eligible if...** - Your cancer did not respond to platinum chemotherapy - You are pregnant or breastfeeding - You have significant other health conditions that would prevent safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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