drugset / Trial / NCT06354231

DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC

NCT06354231

Phase 2 Recruiting 20 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg/kg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg/kg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy. Efficacy and safety were evaluated by cystoscopy, ureteroscopy, laboratory tests, and imaging examinations after treatment.

Timeline

Start
2023-07-20
Primary completion
2026-12-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Disitamab Vedotin Monoclonal antibody 2 mg/kg Intravenous
Subject Toripalimab Monoclonal antibody 3 mg/kg Intravenous