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This study is an interventional, single-arm, open-label clinical trial. To evaluate the safety and efficacy of Fluzoparib as neoadjuvant therapy in patients with FIGO stage III and IV , BRCA mutations or HRD positive epithelial ovarian cancer who cannot achieve R0 surgery as assessed by imaging (Suidan's CT score) or laparoscopy (Fagotti score), or cannot tolerate surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzoparib neoadjuvant therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | Fluzoparib (50mg per capsule) 150mg po bid, with a treatment cycle of 28 days. Administer 2 cycles in total. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate. After completing neoadjuvant monotherapy with Fluzoparib, the proportion of patients who achieve complete response and partial response according to the RECIST 1.1 criteria. | From the diagnosis of epithelial ovarian cancer until the completion of neoadjuvant monotherapy with Fluzoparib, assessed up to 10 weeks. |
| R0 Resection Rate | To evaluate the proportion of patients with advanced epithelial ovarian cancer, initially deemed non-R0 resectable or unable to tolerate surgery, who achieve R0 resection following neoadjuvant monotherapy with Fluzoparib. | From the completion neoadjuvant monotherapy with Fluzoparib until the date of surgery, with the assessment of R0 resection rate occurring within 1 to 2 weeks after treatment completion. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival. The time from patient enrollment to tumor progression or death. | The time from patient enrollment until the date of first documented tumor progression or death from any cause, whichever occurs first, assessed up to 60 months. |
| OS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hualei Bu, PhD | Contact | (+86)053182165881 | buhualei@email.sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250000 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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Overall survival. The time from patient enrollment to death. |
| From the time from patient enrollment until the date of death from any cause, assessed up to 120 months. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |