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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Tislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles.
Nab-Paclitaxel 125mg/m2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles
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.
The Second Hospital of Tianjin Medical University
Tianjin, Outside U.S., China
RECRUITINGPathological Complete Response (pCR)
Defined as no residual tumor in the specimen from distal ureterectomy.
Time frame: At the time of distal ureterectomy completed (within 14 weeks of the treatment initiated)
Treatment-related adverse events (TRAEs)
Treatment-related adverse events (TRAEs) ,defined as adverse events occurring from the start of treatment (C1D1) to 90 days after the completion of the last dose, including type, incidence rate, and severity grading (assessed according to the NCI-CTCAE V5.0 criteria)
Time frame: From neoadjuvant treatment initiation to 90 days after the last cycle of treatment.
Pathological Downstaging (pDS)
Defined as a reduction in the pathological T stage and N stage of the distal ureterectomy specimen compared to the clinical T stage and N stage assessed at baseline
Time frame: At the time of distal ureterectomy completed (within 14 weeks of the treatment initiated)
Objective Response (OR)
Defined as the achievement of partial response (PR) or complete response (CR) based on RECIST 1.1 criteria, as assessed by imaging studies after neoadjuvant therapy.
Time frame: After completion of neoadjuvant therapy and before distal ureterotomy.
Events-Free Survival (EFS)
Defined as the time from treatment initiated to the first occurrence of delayed surgical disease progression, local tumor recurrence (including recurrence in the upper urinary tract and bladder, excluding non-muscle-invasive bladder cancer that can be resected by TURBT), distant metastasis, or death from any cause. The study will record the 1-, 2-, and 5-year EFS rates for the target population. Kaplan-Meier methods will be used to estimate the median EFS and 95% confidence interval limits, and Kaplan-Meier curves will be constructed to provide descriptive information on EFS.
Time frame: up to 5 years
Overall Survival (OS)
Defined as the time from treatment initiated to death from any cause. The study will record the 1-, 2-, and 5-year OS rates for the target population. Kaplan-Meier methods will be used to estimate the median OS and 95% confidence interval limits, and Kaplan-Meier curves will be constructed to provide descriptive information on survival
Time frame: up to 5 years
Recurrence-Free Survival (RFS)
Defined as the time from treatment initiated to the first occurrence of tumor recurrence (including recurrence in the upper urinary tract and bladder, excluding non-muscle-invasive bladder cancer that can be removed by TURBT). The study will record the 1-, 2-, and 5-year RFS rates for the target population. Kaplan-Meier methods will be used to estimate the median RFS and 95% confidence interval limits, and Kaplan-Meier curves will be constructed to provide descriptive information on RFS.
Time frame: up to 5 years
Cancer-Specific Survival (CSS)
Defined as the time from enrollment to death caused by the tumor. The study will record the 1-, 2-, and 5-year CSS rates for the target population. Kaplan-Meier methods will be used to estimate the median CSS and 95% confidence interval limits, and Kaplan-Meier curves will be constructed to provide descriptive information on CSS.
Time frame: up to 5 years
Nephron-Sparing Survival (NSS)
Defined as the time from treatment initiated to the absence of surgical indications for nephrectomy due to upper urinary tract tumor progression or recurrence, as well as the absence of distant metastasis caused by the primary upper urinary tract tumor and death from any cause. The study will record the 1-, 2-, and 5-year NSS rates for the target population. Kaplan-Meier methods will be used to estimate the median NSS and 95% confidence interval limits, and Kaplan-Meier curves will be constructed to provide descriptive information on NSS.
Time frame: up to 5 years
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