Actively Recruiting
Neoadjuvant Tislelizumab + Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer
Led by Tianjin Medical University Second Hospital · Updated on 2025-08-15
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 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.
CONDITIONS
Official Title
Neoadjuvant Tislelizumab + Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Ureteral cancer confirmed by ureteroscopic biopsy and imaging without metastasis (T1-4N0-2M0)
- Histology showing urothelial carcinoma or major component (>50%) urothelial carcinoma
- Planned to receive distal ureterectomy including surgery components specified
- Expected survival time of more than 12 weeks
- ECOG Performance Status of 0 to 2
- Agree to provide blood, urine, and tissue samples for testing
- Organ function meets specified blood counts, liver, and kidney function criteria
- Willing to participate and comply with the study protocol
You will not qualify if you...
- Other active primary cancers, except stable previously treated malignancies
- Bilateral upper tract urothelial carcinoma
- Urothelial carcinoma in renal pelvis or bladder, except fully resected non-muscle-invasive bladder cancer
- Received live vaccine within 4 weeks before or planned during study
- History of autoimmune disease or primary immunodeficiency
- History of organ or stem cell transplant
- Pregnant or breastfeeding
- Untreated active Hepatitis B or C infection unless controlled
- Use of immunosuppressive drugs recently, except specified steroids
- Allergy to Tislelizumab or Nab-Paclitaxel
- Active tuberculosis
- Prior treatment with immune checkpoint inhibitors or similar immunotherapies
- Participation in another clinical trial
- Fertile individuals without effective contraception
- Uncontrolled illnesses including HIV, severe infections, systemic diseases, active bleeding, thrombotic disease, or kidney failure requiring dialysis
AI-Screening
AI-Powered 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, PhD
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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