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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
424
Bevacizumab : 15 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 15 months
150 mg orally bid (50 mg/capsule, 3 capsules/dose)
Control carbohydrate intake in the daily diet
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGTongji Hospital
Wuhan, Hubei, China
RECRUITINGProgression-Free Survival (PFS)
The time from randomization to the occurrence of disease progression (as per RECIST v1.1) or death from any cause, whichever occurs first.
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
Time to Progression (TTP)
The time from randomization to CA125 progression (as per GCIG-CA125 criteria) or disease progression (as per RECIST criteria), whichever occurs first.
Time frame: From date of randomization until the date of first documented CA125 progression (as per GCIG-CA125 criteria) or disease progression (as per RECIST criteria), whichever came first, assessed up to 96 months
Time to Discontinuation or Death (TDT)
The time from randomization to discontinuation of study treatment or death from any cause, whichever occurs first.
Time frame: From date of randomization until the date of first documented discontinuation of study treatment or death from any cause, whichever came first, assessed up to 96 months
ime to First Subsequent Therapy (TFST)
The time from randomization to the initiation of subsequent anti-tumor therapy for ovarian cancer, or death.
Time frame: From date of randomization until the date of first documented initiation of subsequent anti-tumor therapy for ovarian cancer, or death, assessed up to 96 months
Best Overall Response (BOR)
The best objective response recorded from randomization until disease progression or recurrence.
Time frame: From date of randomization until disease progression or recurrence, assessed up to 96 months
Overall Survival (OS)
The time from randomization to death due to any cause.
Time frame: From date of randomization until the date of death from any cause, assessed up to 96 months
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