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Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC

Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for Upper Tract Urothelial Carcinoma: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U02)

NCT07126119•Tianjin Medical University Second Hospital

View on ClinicalTrials.gov

Summary

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females aged no less than 18 years old;
•2. 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.
•3. Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component \>50% in the specimen from ureteroscopic biopsy;
•4. Suitable and planned to receive RNU.
•5. Expected survival time of more than 12 weeks;
•6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
•6.Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, HER-2, tumor mutation burden, etc.); 7.The organ function levels must meet the following requirements: Hematological indicators: Absolute neutrophil count ≥1.5×10\^9/L, platelet count ≥80×10\^9/L, hemoglobin ≥6.0 g/dL (can be maintained through symptomatic treatment); Liver function: Total bilirubin ≤1.5 times the upper limit of normal, alanine transaminase and aspartate transaminase ≤2.5 times the upper limit of normal; Renal function: Baseline ECT renography indicates a total renal glomerular filtration rate (GFR) ≥15 ml/min.
•8.Participants are willing to join the study and be able to sign and comply the protocol.
•10. Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg/day of prednisone or equivalent dose of other corticosteroids);
•11. Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;
+6 more criteria

Exclusion Criteria

•1. 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.
•2. Confirmed bilateral upper tract urothelial carcinoma (UTUC).
•3. 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).
•4. Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;
•5. Active, known or suspected history of autoimmune disease;
•6. Known history of primary immunodeficiency;
•7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
•8. Pregnant or breastfeeding female patients;

Locations (1)

The Second Hospital of Tianjin Medical University

Tianjin, Outside U.S., China

Key Dates

Start Date

July 5, 2025

Primary Completion Date

December 30, 2026

Completion Date

December 30, 2030

Last Updated

August 17, 2025

Enrollment

ESTIMATED participants

Conditions

Upper Tract Urothelial CarcinomaNeoadjuvant TherapyPD-1 InhibitorNab-paclitaxel

Interventions

Nab-Paclitaxel

DRUG

Tislelizumab

DRUG

Radical nephroureterectomy (RNU)

PROCEDURE

Contacts

Hailong Hu

CONTACT

+86 13662096232 Huhailong@tmu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC

Inclusion Criteria

Exclusion Criteria

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