Phase 2 Study of Disitamab Vedotin and Tislelizumab With Kidney-Sparing Surgery in High-Risk Upper Urinary Tract Urothelial Carcinoma

What this Trial Is About

Researchers are evaluating a combination treatment of RC48 and Tislelizumab for patients with high-risk upper urinary tract urothelial carcinoma who are seeking kidney preservation. This Phase 2 clinical study aims to assess the safety and effectiveness of this therapy in helping preserve kidney function while treating the cancer. The study follows strict clinical trial quality standards and will enroll about 20 participants. The treatment involves intravenous administration of RC48 at a dose of 2.0 mgkg every three weeks and Tislelizumab at 200 mg every three weeks. Both drugs are given by intravenous drip over one hour, starting on day 1 of the first 21-day cycle. Participants will receive this combined therapy before undergoing nephron-sparing surgery, aiming to protect kidney function while treating the tumor. During the study, participants will be closely monitored for kidney-intact event-free survival up to one year, along with clinical responses before and after surgery, disease-free survival, and rates of adverse events over two years. Kidney function preservation will be tracked for one year. Participants will provide biopsy tissue and biological samples, and undergo imaging and laboratory tests. The study includes follow-up assessments to evaluate treatment outcomes and safety over time, with total participation lasting up to two years.

Combination of DV and Tislelizumab for Renal Preservation in High-risk UTUC Patients