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RECRUITING
NCT06735326
PHASE2

Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

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.

Official title: A Randomized, Open-Label, Multi-Cohort Study of Fluzoparib Monotherapy or in Combination With Bevacizumab as Neoadjuvant Therapy in Patients With Advanced Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2024-11-27

Completion Date

2028-10-01

Last Updated

2024-12-16

Healthy Volunteers

No

Interventions

DRUG

Fluzoparib

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

DRUG

Bevacizumab

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

DRUG

Paclitaxel

Paclitaxel injection 135-175mg/㎡ ivdrip Q3W

DRUG

Carboplatin

Carboplatin injection AUC=4-5 ivdrip Q3W

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China