eligibility_summary
Adults (≥18) with pathologically confirmed UTUC: high‑risk pT2, or pT3–pT4, or pN+, cisplatin‑ineligible/no platinum adjuvant, no recurrence ≥4 wks post‑op, HER2 IHC 2+/3+, ECOG 0–1, adequate organ function, life expectancy ≥6 mo. Exclude: other active cancers, prior allo‑transplant, recent systemic therapy, immune disorders/immunosuppression, hypersensitivity, recent thrombosis/bleeding, major CV disease, uncontrolled comorbidities/infections, poor surgical recovery, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06210490 tests adjuvant disitamab vedotin (RC48-ADC) plus radiotherapy vs observation in HER2-overexpressing upper tract urothelial carcinoma after radical surgery. Disitamab vedotin is an antibody-drug conjugate: a humanized anti‑HER2 monoclonal antibody linked via a cleavable linker to monomethyl auristatin E (MMAE), a cytotoxic microtubule inhibitor. Mechanism: HER2 binding → internalization → MMAE release → tubulin disruption, G2/M arrest, apoptosis, possible bystander effect. Radiotherapy (45–50 Gy to nodal basins, up to 62.5 Gy to involved nodes) delivers ionizing radiation causing DNA double‑strand breaks and tumor cell death. Targets/pathways: HER2 (ERBB2) on urothelial cancer cells, microtubules/mitotic machinery, and DNA damage/repair pathways (ATM/ATR, NHEJ/HR) in irradiated regions. Standard-of-care arm is observation/supportive care.