RecruitingPhase 2NCT07125547

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

Neoadjuvant Tislelizumab Combined With Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U01)

Sponsor

Tianjin Medical University Second Hospital

Enrollment

35 participants

Start Date

Jul 5, 2025

Study Type

INTERVENTIONAL

Conditions

Neoadjuvant Therapy Tislelizumab PD-1 Inhibitor Ureteral Cancer Kidney-sparing Nab-paclitaxel

Summary

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 5.0.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of neoadjuvant (pre-surgery) therapy using tislelizumab (an immunotherapy drug) plus nab-paclitaxel (a type of chemotherapy) before surgery for people with ureteral cancer (cancer of the tube connecting the kidney to the bladder). **You may be eligible if...** - You are 18 years or older - You have ureteral cancer confirmed by biopsy and imaging (CT, MRI, or PET-CT) - Your cancer has not spread to distant organs (stage T1–T4, N0–N2, M0) - The cancer is primarily urothelial (transitional cell) type - You are in adequate health to receive chemotherapy and immunotherapy **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have had prior immunotherapy or platinum-based chemotherapy for this cancer - You have active autoimmune conditions requiring systemic treatment - You have significant heart, lung, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-1 inhibitior

Tislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles.

DRUGNab-paclitaxel

Nab-Paclitaxel 125mg/m2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles

PROCEDUREdistal ureterectomy

Distal ureterectomy (Distal ureterectomy + Partial cystectomy +Psoas hitch procedure + Ureteral reimplantation into the bladder + Ipsilateral pelvic lymph node dissection) will be conducted after neoadjuvant treatment.