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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| China-Japan Friendship Hospital | OTHER |
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Few previous studies focused on the neoadjuvant treatments of upper urinary or bladder cancer, especially chemotherapy combined with immunotherapy, however, available data of retrospective studies showed this neoadjuvant treatment model might benefit patients. So This prospective Phase II clinical trial was designed to explore the efficacy of chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy in upper urinary and muscle-invasive bladder urothelial carcinoma, then to improve the rate of complete pathological remission, survival and provide medical evidence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIBC Group | Experimental | Muscle-invasive bladder cancer of T2-4aN0M0 confirmed by pathology after maximal transurethral resection of bladder tumors. Enrollment of 30 patients. |
|
| UTUC Group | Experimental | Upper tract urothelial carcinoma of T1-3N0M0 and high grade confirmed by flexible ureteroscope biopsy. Enrollment of 34 patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | Gemcitabine/Cisplatin plus Toripalimab |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response rate | the percentage of pT0N0 patients after operations | through study completion of 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianzhong Shou | Contact | 86-18813019104 | chuanzhenc@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| Jianzhong Shou | National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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