Study of RC48-ADC and JS001 as Postoperative Adjuvant Treatment for HER2-positive Upper Tract Urothelial Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of the combination of intravenous RC48-ADC and JS001 as postoperative adjuvant therapy for patients with HER2-positive upper tract urothelial carcinoma UTUC who have undergone radical nephroureterectomy. This phase 2, open-label, single-arm trial focuses on this specific cancer type characterized by HER2 expression, aiming to improve outcomes after surgery. The study is sponsored by Jinling Hospital, China. Participants will receive six cycles of treatment every three weeks, each including RC48-ADC Disitamab Vedotin at 2 mgkg combined with JS001 Toripalimab at 3 mgkg intravenously. After these initial cycles, participants continue with toripalimab alone every three weeks for up to one year. The study involves a long-term follow-up period to monitor patient progress and treatment impact. Throughout the study, researchers will assess disease-free survival over five years as the primary outcome. Secondary measures include overall survival and metastasis-free survival, both tracked for five years. Participants will be closely monitored for safety and treatment adherence. The total participation duration may extend over several years to fully evaluate long-term outcomes and safety of this adjuvant therapy approach.

A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma