Neoadjuvant Tislelizumab + Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Second Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 chest CT scan and abdominal CT scan (T1-4N0-2M0).
Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component >50% in the specimen from ureteroscopic biopsy;
Suitable and planned to receive distal ureterectomy (including distal ureterectomy + partial cystectomy + ipsilateral pelvic lymph node dissection + psoas hitch procedure + ureteral reimplantation into the bladder).
Disqualifiers
Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.
Confirmed bilateral upper tract urothelial carcinoma (UTUC).
Presence of urothelial carcinoma in the renal pelvis or bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).
Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;
Trial design
Design model
Single group
Treatments tested in this trial
PD-1 inhibitior
DrugTislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles.
Nab-paclitaxel
DrugNab-Paclitaxel 125mg/m2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles
distal ureterectomy
Procedure/SurgeryDistal ureterectomy (Distal ureterectomy + Partial cystectomy +Psoas hitch procedure + Ureteral reimplantation into the bladder + Ipsilateral pelvic lymph node dissection) will be conducted after neoadjuvant treatment.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Arm 1Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Pathological 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)Secondary outcomes
1
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.2
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)3
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.4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov