This study is designed as an open-label, single-arm, single center, phase II clinical trial, aiming to evaluate the efficacy of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo radical nephroureterectomy (RNU). The assessment of efficacy is based on the histology of specimen from RNU, 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
Nab-Paclitaxel 125mg/m\^2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles
Tislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles.
Radical nephroureterectomy (RNU) will conducted after the completion of neoadjuvant therapy.
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 radical nephroureterectomy (RNU).
Time frame: At the time of radical nephroureterectomy (RNU) completed (within 14 weeks of the treatment initiated)
Treatment-related adverse events (TRAEs)
Defined as adverse events that related to neoadjuvant therapy, 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 radical nephroureterectomy (RNU) specimen compared to the clinical T stage and N stage assessed at baseline.
Time frame: At the time of radical nephroureterectomy (RNU) 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 (prior to RNU).
Time frame: After completion of neoadjuvant therapy and before RNU (9 weeks).
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
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