eligibility_summary
Inclusion: Adults with high-risk upper tract urothelial carcinoma (N0/M0, N1 allowed mid/lower ureter), ECOG 0–2, HER2 IHC 0–3+, biopsy/cytology/CT-MRI confirmed, kidney-sparing indication or strong preference, provide tissue/blood/urine, survival ≥3 mo, adequate organs/coagulation, no recent systemic steroids, contraception, consent. Exclusion: prior PD-1/PD-L1, recent antitumor Rx, pregnancy, HIV, active HBV/HCV/TB, autoimmune disease, serious comorbidities, live vaccine, transplant, major surgery, effusions, other cancers, MIBC.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm trial in high-risk upper urinary tract urothelial carcinoma testing RC48 (disitamab vedotin) plus tislelizumab. RC48 is a HER2-directed antibody–drug conjugate (ADC) carrying the microtubule inhibitor MMAE, it binds HER2 on tumor cells, is internalized, releases MMAE to inhibit tubulin polymerization causing mitotic arrest/apoptosis, and may induce ADCC/immunogenic cell death. Tislelizumab is a humanized IgG4 anti–PD-1 checkpoint inhibitor (engineered to reduce FcγR binding) that blocks PD-1 to restore antitumor T‑cell activity. Targets/pathways: HER2 on urothelial cancer cells, microtubules (tubulin), PD‑1 on T cells and the PD‑1/PD‑L1 axis in the tumor microenvironment. Goal: kidney-preserving therapy in high‑risk UTUC.