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

Sponsor
Tongji Hospital
Study ID
NCT06954584
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 1, 2025
Start date
May 27, 2025
Status verified
Jun 2025
Primary completion
May 1, 2030
Completion
Mar 1, 2032

Study Design

Enrollment
424 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HRD-Positive Cohort (Experimental Group): Fluzoparib + Bevacizumab
    Fluzoparib Capsules : 150 mg orally twice daily (bid) (50 mg/capsule, 3 capsules/dose) . Bevacizumab : 15 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 15 months .
  • Active Comparator: HRD-Positive Cohort (Control Group): Fluzoparib Monotherapy
    Fluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)
  • Experimental: HRD-Negative Cohort (Experimental Group 1): Fluzoparib + Dietary Intervention
    Fluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)
  • Experimental: HRD-Negative Cohort (Experimental Group 2): Fluzoparib Monotherapy
    Fluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months ]

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