Actively Recruiting
Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC
Led by Tianjin Medical University Second Hospital · Updated on 2025-08-17
35
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with non-metastatic UTUC confirmed by biopsy and imaging (CT, MRI, or PET-CT) with no chest or abdominal metastasis
- Histologically confirmed urothelial carcinoma or major component (>50%) in biopsy specimen
- Suitable and planned for radical nephroureterectomy surgery
- Expected survival time longer than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Willing to provide blood, urine, and tissue samples for biomarker testing
- Organ function within specified limits: neutrophil count ≥1.5×10^9/L, platelet count ≥80×10^9/L, hemoglobin ≥6.0 g/dL (symptomatic treatment allowed), liver enzymes and bilirubin within defined limits, renal function with GFR ≥15 ml/min
- Willing and able to comply with study protocol and provide informed consent
You will not qualify if you...
- Having other active primary cancers except stable treated past malignancies
- Confirmed bilateral UTUC
- Presence of urothelial carcinoma in bladder except completely resected non-muscle-invasive bladder cancer
- Received live attenuated vaccine within 4 weeks before or planned during study
- Active or suspected autoimmune disease
- History of primary immunodeficiency
- History of allogeneic organ or hematopoietic stem cell transplantation
- Pregnant or breastfeeding
- Untreated active Hepatitis B or C infection
- Receiving immunosuppressive medication within 4 weeks before treatment, except certain steroids
- Known allergy to Tislelizumab or Nab-Paclitaxel
- Active tuberculosis
- Previous treatment with PD-1/PD-L1/CTLA-4 inhibitors or other immunotherapies
- Participation in another clinical trial
- Fertile men or women without effective contraception
- Uncontrolled illness including HIV infection, severe infection, severe psychiatric or neurological disorders, unstable respiratory, cardiovascular, liver or kidney disease, uncontrolled hypertension grade 2 or higher, active bleeding or thrombotic disease, or renal failure requiring dialysis
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Hospital of Tianjin Medical University
Tianjin, Outside U.S., China, 300211
Actively Recruiting
Research Team
H
Hailong Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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