A Prospective, Open-label, Single-arm, Clinical Study of Disitamab Vedotin Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple Upper Urinary Tract Urothelial Carcinoma
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.
• ≥18 years old;
• Histologically confirmed isolated renal or renal insufficiency or bilateral upper urinary tract urothelial carcinoma;
• Refusal or ineligibility for RNU;
• Preoperative risk stratification was defined as high-risk UTUC, defined as patients with any of the following factors:
‣ Hydronephrosis;
⁃ Tumor diameter ≥2cm;
⁃ Urine cytology suggests a high-grade tumor;
⁃ A ureteroscopic biopsy suggests a high-grade tumor;
⁃ CT showed a localized invasion;
⁃ Multifoci diseases;
⁃ With multiple histological subtypes;
• ECOG 0\
∙ 1;
• Major organ function is normal (14 days prior to enrollment) if the following criteria are met:
‣ The blood routine examination criteria should meet (no blood transfusion and no granulocyte colony stimulation agent treatment within 14 days before enrollment): HB≥90 g/L; ANC≥1.5×109 /L; PLT≥100×109 /L;
⁃ Non-functional organic diseases shall meet the following criteria: T-BIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5 x ULN; Serum creatinine ≤2×ULN, or endogenous creatinine clearance ≥ 30ml/min(Cockcroft-Gault formula);
• Subjects (or their legal representatives) must sign an informed consent form (ICF) indicating that they understand the purpose and procedures of the study and are willing to participate in the study.
• Pregnant women must have a negative pregnancy test result (beta-hCG) (urine or serum) within 7 days before the first administration of the randomized or study drug.