Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Local Advanved Bladder Cancer
NCT04553939 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-01-02
Summary
This is a pre-surgical study involving subjects with muscle invasive bladder urothelial cancer, who are candidates for cisplatin ineligible neoadjuvant therapy. It is a one-arm phase II study in single center.
Conditions
Interventions
- DRUG
-
Toripalimab
Toripalimab 3mg/m2 ivgtt, D1 every 14 days for 2-4 cycles.
- DRUG
-
Gemcitabine 800mg/m2 ivgtt, D1 every 14 days for 2-4 cycles.
Sponsors & Collaborators
-
Henan Cancer Hospital
lead OTHER_GOV
Principal Investigators
-
zhao Shiming · Henan Cancer Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-04
- Primary Completion
- 2023-04-12
- Completion
- 2025-04-12
Countries
- China
Study Locations
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