Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: MIBC Group Muscle-invasive bladder cancer of T2-4aN0M0 confirmed by pathology after maximal transurethral resection of bladder tumors. Enrollment of 30 patients. |
Drug: Toripalimab
Gemcitabine/Cisplatin plus Toripalimab
|
Experimental: UTUC Group Upper tract urothelial carcinoma of T1-3N0M0 and high grade confirmed by flexible ureteroscope biopsy. Enrollment of 34 patients. |
Drug: Toripalimab
Gemcitabine/Cisplatin plus Toripalimab
|
Outcome Measures
Primary Outcome Measures
- pathological complete response rate [through study completion of 3 years]
the percentage of pT0N0 patients after operations
Eligibility Criteria
Criteria
Inclusion Criteria:
-
bladder cancer of T2-4aN0M0
-
upper tract urinary carcinoma of T1-3N0M0 and high grade
-
ECOG 0-1
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good organ function
-
no previous chemotherapy or immunotherapy
-
Informed consent form signed
Exclusion Criteria:
-
unable to receive chemotherapy or surgery due to physical abnormalities
-
previous cancer history
-
active tuberculosis
-
HIV
-
autoimmune disease
-
anticipating other clinical studies
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing | China | 100021 |
Sponsors and Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Peking University First Hospital
- China-Japan Friendship Hospital
Investigators
- Principal Investigator: Jianzhong Shou, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCC2121