This study is a randomized, open-label, multi-cohort, multicenter clinical trial, aimed at evaluating the efficacy and safety of Fluzoparib monotherapy, Fluzoparib in combination with Bevacizumab, and standard chemotherapy (Paclitaxel plus Carboplatin) as neoadjuvant treatments in newly diagnosed, germline BRCA1/2-mutated epithelial ovarian cancer patients (FIGO stage III/IV). The study also aims to assess the efficacy and safety of Fluzoparib as maintenance therapy following surgery and chemotherapy. The primary endpoint of the study is the objective response rate (ORR) for neoadjuvant therapy, as assessed by the investigator using RECIST v1.1 criteria. Secondary endpoints include R0 resection rate, overall survival (OS), and progression-free survival (PFS). The study will also evaluate the safety, tolerability, and patient-reported outcomes (EQ-5D-5L) across the three treatment cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Fluzoparib capsule (50mg per capsule) 150mg po BID
Bevacizumab injection (100mg per vial) 7.5mg/kg ivdrip Q3W
Paclitaxel injection 135-175mg/㎡ ivdrip Q3W
Carboplatin injection AUC=4-5 ivdrip Q3W
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGObjective Response Rate (ORR)
The percentage of patients who achieve a complete response (CR) or partial response (PR) as determined by the investigator based on RECIST v1.1 criteria, at the end of neoadjuvant treatment.
Time frame: At the end of neoadjuvant treatment. The Fluzoparib monotherapy and Fluzoparib plus Bevacizumab groups will receive 2 cycles of treatment (28 days per cycle). The Paclitaxel plus Carboplatin group will receive 3 cycles of treatment (21 days per cycle).
R0 resection rate
To evaluate the proportion of patients who achieve R0 resection following neoadjuvant therapy.
Time frame: Immediately after final interval debulking surgery.
pCR
Pathological complete response.
Time frame: Post-surgical pathology (up to 2 weeks post surgery).
Overall survival (OS)
The time from patient enrollment to death.
Time frame: The time from patient enrollment until the date of death from any cause, assessed up to 120 months.
Progression free survival (PFS)
The time from patient enrollment to tumor progression or death.
Time frame: The time from patient enrollment until the date of first documented tumor progression or death from any cause, whichever occurs first, assessed up to 60 months.
Safety evaluation
Adverse events (AEs) during neoadjuvant treatment, surgery, chemotherapy, and maintenance therapy, grading based on NCI-CTCAE v5.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0). AEs are generally graded from 1 to 4, with higher grades indicating more worse conditions.
Time frame: From the start of neoadjuvant therapy to the end of maintenance therapy, assessed up to 30 months.
Tolerability evaluation
The proportion of dose interruptions, dose reductions, and dose discontinuations due to drug-related toxicities during the trial.
Time frame: From the start of neoadjuvant therapy to the end of maintenance therapy, assessed up to 30 months.
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