eligibility_summary
Adults (≥18) with HER2+ (IHC 1–3+) very high‑risk NMIBC (Ta/Tis/T1 UCC, CIS allowed, papillary tumors resected, first dose ≤12 wks post‑TURBT), refusing/unsuitable for cystectomy, ECOG 0–1, adequate organs (CrCl ≥30), consent, women test negative. Exclude MIBC/metastatic/upper tract (unless disease‑free ≥2y), non‑UCC histology, prior anti‑HER2, most active cancers (select exceptions), major CV/QTc>480/recent VTE, pregnancy/lactation, active HBV/HCV, uncontrolled HIV, unresolved AEs, poor healing, major surgery <4 wks, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions and mechanisms: 1) Disitamab vedotin (RC48): an anti‑HER2 antibody–drug conjugate (ADC) delivering the microtubule inhibitor MMAE via a cleavable linker. Binds HER2 on urothelial tumor cells, is internalized, releases MMAE to disrupt microtubules (G2/M arrest → apoptosis), with potential bystander effect and Fc‑mediated ADCC. 2) Intravesical BCG (live attenuated Mycobacterium bovis): immunotherapy that activates bladder mucosal innate and adaptive immunity, triggering TLR2/4 and NOD2 signaling, Th1‑skewed cytokines (IFN‑γ, IL‑2, TNF‑α), and recruitment/activation of macrophages, dendritic cells, NK cells, and cytotoxic T cells to kill tumor cells. Targets/pathways: HER2‑expressing urothelial carcinoma cells, microtubule polymerization, innate/adaptive immune pathways leading to CD8+ T‑cell and NK cell–mediated tumor lysis.