Phase II Study of Neoadjuvant Tislelizumab and Nab-Paclitaxel Followed by Surgery for Treating Upper Tract Urothelial Carcinoma

What this Trial Is About

Researchers are evaluating the effect of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma UTUC. This phase II, open-label, single-arm trial aims to assess the treatments impact on tumor response by examining tissue samples collected after surgery. Treatment-related side effects will also be monitored using standard criteria to understand safety. Participants will receive 2 to 3 cycles of Nab-Paclitaxel at 125 mgm and Tislelizumab at 200 mg intravenously every three weeks. Following this treatment, patients will undergo radical nephroureterectomy RNU, a surgical procedure to remove the kidney and ureter. The timing of surgery is planned within 14 weeks after starting treatment. During the study, participants will have assessments including biopsy and imaging before treatment, and pathological evaluation of the surgical specimen after RNU. Researchers will track pathological complete response as the main outcome, along with adverse events, tumor downstaging, and survival outcomes for up to five years. Blood, urine, and tissue samples will be collected to study biomarkers. Careful monitoring of side effects and health status will continue throughout and after treatment.

Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC