Clinical trial · Interventional
Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
Multicenter Phase II Study of Gemcitabine/Cisplatin (GC) Chemotherapy Combined With PD-1 Inhibitor (Toripalimab) in the Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle-invasive Bladder Cancer | — | UNRESOLVED | — |
| Upper Tract Urinary Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MIBC Group
- description
- Muscle-invasive bladder cancer of T2-4aN0M0 confirmed by pathology after maximal transurethral resection of bladder tumors. Enrollment of 30 patients.
- interventionNames
- Drug: Toripalimab
- type
- EXPERIMENTAL
- label
- UTUC Group
- description
- Upper tract urothelial carcinoma of T1-3N0M0 and high grade confirmed by flexible ureteroscope biopsy. Enrollment of 34 patients.
- interventionNames
- Drug: Toripalimab
Primary outcomes (1)
- measure
- pathological complete response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. bladder cancer of T2-4aN0M0 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: 1. unable to receive chemotherapy or surgery due to physical abnormalities 2. previous cancer history 3. active tuberculosis 4. HIV 5. autoimmune disease 6. anticipating other clinical studies
References
Publications (0)
Data not yet available