Neoadjuvant Tislelizumab + Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer

This study is designed as an open-label, single-arm, single-center, phase II clinical trial, aiming to evaluate the efficacy and safety of neoadjuvant Tislelizumab combined with Nab-Paclitaxel followed by distal ureterectomy for patients with non-metastatic ureteral cancer (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo distal ureterectomy (DU). The assessment of efficacy is based on the histology of specimen from DU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE

Trial Details

NCT ID
NCT07125547
Phase
PHASE2
Sponsor
Tianjin Medical University Second Hospital
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • PD-1 inhibitior
  • Nab-paclitaxel
  • distal ureterectomy
Locations (sample)
  • Tianjin, Outside U.S., China|39.14222,117.17667

Key Eligibility Criteria

  • Males or females aged no less than 18 years old;
  • Ureteral cancer indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in …
  • Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component \>50% in the specimen from ureteroscopic …
  • Suitable and planned to receive distal ureterectomy (including distal ureterectomy + partial cystectomy + ipsilateral pelvic lymph node dissection …

For full eligibility, visit ClinicalTrials.gov.

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