Phase II Study of Kidney-Sparing Treatment Using Tislelizumab and Nab-Paclitaxel for Renal Pelvic Cancer

What this Trial Is About

Researchers are evaluating a nephron-sparing treatment combining Tislelizumab and Nab-Paclitaxel for patients with HER-2 expressing renal pelvic cancer. This open-label, single-arm, phase II trial aims to assess the effectiveness and safety of this combined approach to control tumors while preserving kidney function. The study focuses on patients with localized upper tract urothelial carcinoma without metastasis, treated at a single center. Participants will receive 2 to 3 cycles of Tislelizumab and Nab-Paclitaxel every 3 weeks. After initial treatment, patients are evaluated for tumor response and tolerance. Those meeting criteria for complete or partial response, tolerating treatment well, and willing to continue will undergo ureteroscopic biopsy. If residual lesions are found, endoscopic interventions such as laser ablation or cryoablation will be performed. Qualified patients then continue with at least 2 cycles of maintenance therapy with the same drugs. Patients not meeting criteria are advised to have salvage radical nephroureterectomy and are excluded from further study treatment. Throughout the study, participants will undergo assessments including biopsies, imaging, and laboratory tests to monitor tumor status and side effects up to 1 year and longer for survival outcomes. Treatment-related adverse events will be recorded and evaluated. The primary measure is one-year nephron-sparing survival, defined as avoiding surgery due to progression or death within one year. Additional outcomes include response rates, survival measures up to 5 years, and safety monitoring. The total participation timeline extends from treatment initiation through follow-up evaluations.

Nephron-sparing Treatment of Tislelizumab + Nab-Paclitaxel for Renal Pelvic Cancer