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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date changed from estimate of Dec 30, 2025 to Nov 3, 2025
    • Secondary endpoints: 4 to 6
    • Study title revised
    • Eligibility criteria shortened, about 3 words
    v5
  2. Primary endpoint revised
    • Secondary endpoints revised (4)
    v4
  3. Primary endpoint revised
    • Eligibility criteria revised
    • Secondary endpoints: 2 to 4
    • Collaborators expanded, about 12 words
    v3
  4. Primary completion date: Dec 10, 2025 to Dec 30, 2025
    • Study completion date: Dec 10, 2026 to Dec 30, 2026
    • Eligibility criteria revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RenJi Hospital
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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).
Trial Details
NCT Number NCT05912816
Lead Sponsor RenJi Hospital
Collaborators: Tianjin Medical University Second Hospital, Peking University First Hospital, West China Hospital
Conditions
(from sponsor)		 Upper Urinary Tract Urothelial Carcinoma, Kidney Preservation, HER-2 ADC, PD-1antibody
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov