OncoMatch/Clinical Trials/NCT06735326
Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer
Is NCT06735326 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Fluzoparib and Bevacizumab for ovarian cancer.
Treatment: Fluzoparib · Bevacizumab · Paclitaxel · Carboplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Required: BRCA1 germline mutation
Required: BRCA2 germline mutation
Disease stage
Required: Stage FIGO III, FIGO IV (FIGO)
Grade: high-grade, moderate/low-grade, grade ≥II
FIGO stage III-IV high-grade (or moderate/low-grade) serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; grade ≥II endometrioid adenocarcinoma of the ovary
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: PARP inhibitor
Patients who have previously received treatment with known or potential PARP inhibitors
Cannot have received: VEGF inhibitor (bevacizumab)
Patients who have previously received treatment with ... Bevacizumab
Cannot have received: radiotherapy
Exception: less than 4 weeks since last dose
Patients who have previously received radiotherapy, chemotherapy, hormonal therapy, or molecular targeted therapy, with less than 4 weeks since the last dose of treatment (less than 5 half-lives for oral molecular-targeted agents)
Cannot have received: chemotherapy
Exception: less than 4 weeks since last dose
Patients who have previously received radiotherapy, chemotherapy, hormonal therapy, or molecular targeted therapy, with less than 4 weeks since the last dose of treatment (less than 5 half-lives for oral molecular-targeted agents)
Cannot have received: hormonal therapy
Exception: less than 4 weeks since last dose
Patients who have previously received radiotherapy, chemotherapy, hormonal therapy, or molecular targeted therapy, with less than 4 weeks since the last dose of treatment (less than 5 half-lives for oral molecular-targeted agents)
Cannot have received: molecular targeted therapy
Exception: less than 4 weeks since last dose (less than 5 half-lives for oral molecular-targeted agents)
Patients who have previously received radiotherapy, chemotherapy, hormonal therapy, or molecular targeted therapy, with less than 4 weeks since the last dose of treatment (less than 5 half-lives for oral molecular-targeted agents)
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5 × 10^9/L; Platelet count ≥100 × 10^9/L; Hemoglobin ≥9 g/dL
Kidney function
Serum creatinine ≤1.5x ULN, or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)
Liver function
Bilirubin ≤1.5x ULN; ALT and AST ≤2.5x ULN, must be ≤5x ULN in the presence of liver metastases
Function of major organs meets the following requirements ... (see details in criteria 9)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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