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This trial aims to prospectively assess the safety and efficiency of Fluzoparib in metastatic non-clear cell renal cell carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Fluzoparib alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | Fluzoparib |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate(ORR) | the proportion of patients with CR, PR, and SD in the group(RECIST1.1) | three months |
| Measure | Description | Time Frame |
|---|---|---|
| radiographic progression free survival(rPFS) | the time frame from the first day of fluzoparib to the date of radiographic confirmed progressive disease or death which one occurrs first | six months |
| overall survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongqian Guo, Phd | Department of Urology, Drum Tower Hospital, Medical School of Nanjing University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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the time frame from the first day of fluzoparib to the date of death the time frame from the first day of apatinib to the date of death the time frame from the first day of apatinib to the date of death the time frame from the first day of apatinib to the date of death the time frame from the first day of apatinib to the date of death
| eighteen months |
| time to progression(TTP) | the time frame from the first day of fluzoparib to the date of confirmed progressive | six months |
| AE | Number of Adverse Events, Grade 3 or higher as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 2 years |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |