Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer
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-muta
| Condition(s) | Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 t |
| Who can participate | Inclusion Criteria: 1. The subject voluntarily agrees to participate and signs the informed consent form. 2. Age ≥18 years (calculated as of the date of signing the informed consent). 3. Pathologically diagnosed with newly diagnosed, 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; Mixed tumors: high-grade serous or ≥II grade endometrioid component must be \>50%. 4. The subject has at least one measurable lesion that can be assessed by CT or MRI (RECIST v1.1). 5. According to the investigator's assessment, the patient is unable to achieve R0 resection or cannot tolerate surgery. a) Criteria for determining inability to achieve R0 resection include: i. Fagotti |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Qilu Hospital of Shandong University |
| Locations | Jinan, Shandong, China |
| Start date | 2024-11-27 |
| NCT ID | NCT06735326 |
| Official listing | https://clinicaltrials.gov/study/NCT06735326 |