Clinical Trial

Combination of DV and Tislelizumab for Renal Preservation in High-risk UTUC Patients

Recruiting Phase 2

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).

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2023-06-20; most recent amendment 2025-12-02.

Trial Details

NCT Number	NCT05912816
Lead Sponsor	RenJi Hospital Collaborators: Tianjin Medical University Second Hospital, Peking University First Hospital, West China Hospital
Conditions	Upper Urinary Tract Urothelial Carcinoma, Kidney Preservation, HER-2 ADC, PD-1antibody
Enrollment	20 participants
Start Date	2023-06-10
Primary Completion	2025-11-03 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-12-09