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Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC

ConditionsUpper Tract Urothelial CarcinomaNeoadjuvant TherapyPD-1 InhibitorNab-paclitaxel
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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females aged no less than 18 years old;

UTUC 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); High risk disease confirmed in accordance with the EAU guidelines.

Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component >50% in the specimen from ureteroscopic biopsy;

Suitable and planned to receive RNU.

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 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

  • Nab-Paclitaxel

    Drug

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

  • Tislelizumab

    Drug

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

  • Radical nephroureterectomy (RNU)

    Procedure/Surgery

    Radical nephroureterectomy (RNU) will conducted after the completion of neoadjuvant therapy.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Arm 1Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathological 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)

Secondary outcomes

1

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.
2

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)
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 (prior to RNU).

Time frame
After completion of neoadjuvant therapy and before RNU (9 weeks).
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 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Second Hospital

Lead sponsor

Source ClinicalTrials.gov
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