eligibility_summary
Adults 18–85, ECOG 0–2, ≥1-year survival, adequate organ function, completed screening, and suitable for TURBt. NMIBC (AUA high/very high risk), urothelial-predominant (≥50%), HER2 IHC 2+/3+, maximal TURBt ≤6 weeks. Prior systemic therapy allowed except immunotherapy/ADC. Exclude immunodeficiency/infections/TB, severe comorbidities, other cancers, low/intermediate NMIBC or ≥T2 or HER2≤1+, recent therapy (<4 wks), pregnancy, anatomic limits, major lab dysfunction, recent trials, substance dependence.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06630871 in high-/very high-risk HER2 2+/3+ non–muscle invasive bladder cancer. Interventions: 1) Disitamab vedotin (RC48), an anti‑HER2 antibody–drug conjugate (ADC) carrying MMAE. Mechanism: binds HER2 on tumor cells, internalizes, releases MMAE to inhibit microtubule polymerization → mitotic arrest/apoptosis, may also mediate ADCC. 2) Tislelizumab, a monoclonal antibody immune checkpoint inhibitor targeting PD‑1. Mechanism: blocks PD‑1/PD‑L1 signaling to reinvigorate cytotoxic T‑cell responses and antitumor immunity. 3) Re‑TURBT (repeat transurethral resection): surgical debulking/restaging to remove residual lesions. Cells/pathways targeted: HER2/ERBB2‑overexpressing urothelial carcinoma cells, microtubule dynamics via MMAE, PD‑1 pathway on exhausted T cells and PD‑L1 on tumor/immune cells within the tumor microenvironment.