Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer
A Randomized, Open-Label, Multi-Cohort Study of Fluzoparib Monotherapy or in Combination With Bevacizumab as Neoadjuvant Therapy in Patients With Advanced Ovarian Cancer
Qilu Hospital of Shandong University
105 participants
Nov 27, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06735326