eligibility_summary
Adults (≥18) with high‑risk UTUC (hydronephrosis, tumor ≥2 cm, high‑grade cytology/biopsy, CT invasion, multifocal or mixed histology), with solitary kidney/renal insufficiency or bilateral disease, who refuse/are ineligible for RNU, ECOG 0–1, adequate labs, consent, negative pregnancy test. Excludes: small cell/pure adeno/squamous/CIS, prior PD‑1/PD‑L1/HER2, active other cancers, major CV/VTE, active HBV/HCV, uncontrolled HIV, unresolved AEs, poor healing, recent major surgery.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06354231 tests disitamab vedotin (DV, RC48) plus toripalimab with kidney-sparing laser surgery in upper tract urothelial carcinoma. DV is an antibody–drug conjugate (anti‑HER2 mAb linked to MMAE, a microtubule inhibitor), it binds HER2 on tumor cells, is internalized, releases MMAE to disrupt microtubules, cause G2/M arrest and apoptosis, with potential bystander effect. Toripalimab (JS001) is a humanized IgG4 monoclonal antibody checkpoint inhibitor targeting PD‑1, blocking PD‑1/PD‑L1 to reinvigorate cytotoxic T‑cell antitumor immunity. Targets/cells/pathways: HER2 (ERBB2) on urothelial carcinoma cells, microtubules in tumor cells, PD‑1 on T cells and the PD‑1/PD‑L1 checkpoint axis in the tumor microenvironment. Laser surgery mechanically ablates ureter/renal pelvis tumors to preserve renal function. Phase 2, single‑arm, China.