drugset / Trial / NCT05912816
Combination of DV and Tislelizumab for Renal Preservation in High-risk UTUC Patients
Phase 2
Recruiting
20 enrolled
RenJi Hospital
Peking University First Hospital · collabTianjin Medical University Second Hospital · collabWest China Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective, open, multiple-center clinical study of renal preservation therapy in high-risk upper urinary tract urothelial carcinoma patients . The study was conducted in accordance with the Good Practice for Quality Control of Clinical Trials for Pharmaceutical Products (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (2.0 mg/kg intravenously every 3 weeks) combined with Tislelizumab (200mg intravenously every 3 weeks).
Timeline
- Start
- 2023-06-10
- Primary completion
- 2025-11-03
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Disitamab Vedotin | Other / unclassified | 2 mg/kg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |