Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
NCT ID: NCT04099589
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
64 participants
INTERVENTIONAL
2019-10-01
2022-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MIBC Group
Muscle-invasive bladder cancer of T2-4aN0M0 confirmed by pathology after maximal transurethral resection of bladder tumors. Enrollment of 30 patients.
Toripalimab
Gemcitabine/Cisplatin plus Toripalimab
UTUC Group
Upper tract urothelial carcinoma of T1-3N0M0 and high grade confirmed by flexible ureteroscope biopsy. Enrollment of 34 patients.
Toripalimab
Gemcitabine/Cisplatin plus Toripalimab
Interventions
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Toripalimab
Gemcitabine/Cisplatin plus Toripalimab
Eligibility Criteria
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Inclusion Criteria
2. upper tract urinary carcinoma of T1-3N0M0 and high grade
3. ECOG 0-1
4. good organ function
5. no previous chemotherapy or immunotherapy
6. Informed consent form signed
Exclusion Criteria
2. previous cancer history
3. active tuberculosis
4. HIV
5. autoimmune disease
6. anticipating other clinical studies
18 Years
75 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Jianzhong Shou
Professor
Principal Investigators
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Jianzhong Shou
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCC2121
Identifier Type: -
Identifier Source: org_study_id
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