eligibility_summary
Key eligibility: Adults ≥18, ECOG 0–1, T2 bladder urothelial carcinoma (urothelial >50%) planned for bladder-sparing therapy, IHC 2+/3+, life expectancy ≥3 months, adequate organ function/blood counts, no systemic steroids within 4 weeks, contraception, consent. Exclude: recent anti-tumor therapy or unresolved toxicity, pregnancy/lactation, HIV, active HBV/HCV/TB, recent active autoimmune disease, serious comorbidities, upper tract UC, investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05912205: Single-arm phase II testing disitamab vedotin (RC48) plus bladder radiotherapy as bladder-preserving therapy after maximal TURBT in muscle-invasive, HER2-positive urothelial carcinoma (IHC 2+/3+). Disitamab vedotin is a HER2-directed antibody–drug conjugate (ADC) that binds HER2 (ERBB2) on tumor cells, is internalized, and releases the microtubule inhibitor MMAE to block microtubule polymerization, causing mitotic arrest and apoptosis, its IgG1 backbone can also mediate ADCC and a bystander effect. Stereotactic body radiotherapy (>50 Gy) delivers localized ionizing radiation that induces DNA double-strand breaks, tumor cell death, and may enhance antitumor immunity. Targets: HER2-expressing urothelial carcinoma cells, HER2 signaling, microtubules/mitosis, and DNA damage/repair pathways.