RecruitingPhase 2NCT06735326

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


Sponsor

Qilu Hospital of Shandong University

Enrollment

105 participants

Start Date

Nov 27, 2024

Study Type

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — fluzoparib (a PARP inhibitor that blocks cancer cell repair) with or without bevacizumab (a drug that cuts off blood supply to tumors) — as initial treatment before surgery in patients with advanced ovarian, fallopian tube, or peritoneal cancer. **You may be eligible if...** - You are 18 years of age or older - You have been newly diagnosed with Stage III or IV high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer - You have at least one measurable tumor on imaging - You have not received any prior treatment for this cancer **You may NOT be eligible if...** - You have already received treatment for ovarian cancer - You do not have measurable disease on imaging - Your organ function is too poor to tolerate treatment 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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Interventions

DRUGFluzoparib

Fluzoparib capsule (50mg per capsule) 150mg po BID

DRUGBevacizumab

Bevacizumab injection (100mg per vial) 7.5mg/kg ivdrip Q3W

DRUGPaclitaxel

Paclitaxel injection 135-175mg/㎡ ivdrip Q3W

DRUGCarboplatin

Carboplatin injection AUC=4-5 ivdrip Q3W


Locations(1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT06735326


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