Phase II Trial of Neoadjuvant Gemcitabine and Trastuzumab Rezetecan for HER2-Positive Upper Tract Urothelial Carcinoma Treatment

What this Trial Is About

Researchers are studying upper tract urothelial carcinoma UTUC, a condition with a poor outlook when treated with conventional chemotherapy regimens. This trial focuses on patients with HER2 2-3 UTUC and aims to evaluate the effectiveness and safety of combining Trastuzumab Rezetecan, an anti-HER2 antibody-drug conjugate, with gemcitabine. This phase II study explores a new treatment approach due to limitations of traditional cisplatin-based chemotherapy. Participants will receive intravenous infusions of gemcitabine followed by Trastuzumab Rezetecan every 21 days. The treatment includes four cycles of neoadjuvant therapy before surgery. After surgery, patients who do not achieve a complete pathological response will receive two additional cycles of adjuvant therapy. Those with suboptimal pathological downstaging after surgery may also receive immune checkpoint inhibitors as a combination therapy. During the neoadjuvant period, side effects will be closely monitored. Participants will undergo regular imaging and follow-up assessments to track disease recurrence and progression. The main outcome measured is the pathological complete response rate shortly after surgery. Secondary outcomes include adverse events during neoadjuvant therapy, event-free survival, and overall survival. The total study duration extends until August 2029.

Neoadjuvant Gemcitabine Plus Trastuzumab Rezetecan in HER2-positive UTUC