Study of Disitamab Vedotin and Radiotherapy for High-Risk HER2-Positive Upper Urinary Tract Urothelial Carcinoma After Surgery

What this Trial Is About

This research investigates the safety and effectiveness of disitamab vedotin combined with radiotherapy for patients with upper urinary tract urothelial carcinoma UTUC who have high-risk factors for recurrence after radical surgery. The study involves 60 patients with HER2 overexpression and aims to evaluate disease-free survival and other outcomes over time. Patients are grouped based on their choice to receive adjuvant therapy or to undergo close observation with supportive care. Patients in the adjuvant therapy group receive disitamab vedotin, a targeted drug, alongside radiotherapy. The radiotherapy dose targets lymph node areas and metastatic sites over a 5-week period. The disitamab vedotin treatment lasts for 6 months. Those in the non-adjuvant group do not receive this therapy but are closely monitored. Safety and effectiveness assessments continue throughout the study, including follow-up after treatment completion. Participants will have regular safety checks before each treatment dose and for 30 days after the last dose or new antitumor therapy starts. Tumor and health assessments occur every 12 weeks for about 2 years or until tumor recurrence or other study endpoints. If disease progresses, follow-up continues every 3 months to track survival and further treatments. The study collects data on overall survival, recurrence, tumor markers, physical status, and adverse events to understand the treatment impact and safety.

A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery