Study of Disitamab Vedotin and Toripalimab With Laser Surgery to Preserve Kidney Function in Patients With Solitary Kidney, Renal Insufficiency, or Bilateral Upper Urinary Tract Urothelial Carcinoma

What this Trial Is About

This research aims to assess the effectiveness and safety of combining Disitamab Vedotin DV and Toripalimab in patients with renal insufficiency, solitary kidney, or bilateral multiple upper urinary tract urothelial carcinoma UTUC. The study will enroll about 20 participants who have refused or are ineligible for radical nephroureterectomy RNU, focusing on preserving kidney function while treating cancer. It is a phase 2 clinical trial led by Fudan University. Participants will receive DV at a dose of 2.0 mgkg and Toripalimab at 3.0 mgkg, both given intravenously every two weeks. The treatment consists of 6 cycles of these drugs followed by laser surgery to remove tumors from the ureter or renal pelvis. After surgery, participants will continue with 12 more cycles of DV and one year of Toripalimab as consolidation therapy to support ongoing disease control. Throughout the study, participants will undergo cystoscopy, ureteroscopy, laboratory tests, and imaging scans to monitor treatment effects and safety. The primary outcome is kidney-intact disease-free survival measured up to 12 months. Secondary outcomes include time to disease progression, time to radical nephroureterectomy, disease-specific survival, overall survival, and complete remission rates up to three years. The total study period extends through treatment and follow-up, with careful monitoring of kidney preservation and cancer control.

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