Actively Recruiting
Neoadjuvant Tislelizumab with Nab-Paclitaxel for Upper Tract Urothelial Carcinoma: An Open-Label Phase II Trial
Led by Tianjin Medical University Second Hospital · Updated on 2025-08-17
35
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma (UTUC). This phase II, open-label, single-arm trial aims to assess the treatment's impact on tumor response by examining tissue samples collected after surgery. Treatment-related side effects will also be monitored using standard criteria to understand safety. Participants will receive 2 to 3 cycles of Nab-Paclitaxel at 125 mg/m² and Tislelizumab at 200 mg intravenously every three weeks. Following this treatment, patients will undergo radical nephroureterectomy (RNU), a surgical procedure to remove the kidney and ureter. The timing of surgery is planned within 14 weeks after starting treatment. During the study, participants will have assessments including biopsy and imaging before treatment, and pathological evaluation of the surgical specimen after RNU. Researchers will track pathological complete response as the main outcome, along with adverse events, tumor downstaging, and survival outcomes for up to five years. Blood, urine, and tissue samples will be collected to study biomarkers. Careful monitoring of side effects and health status will continue throughout and after treatment.
CONDITIONS
Brief 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
- Upper tract urothelial carcinoma confirmed by biopsy and imaging without metastasis
- High-risk disease confirmed per EAU guidelines
- Histologically confirmed urothelial carcinoma with over 50% major pathological component
- Suitable and planned for radical nephroureterectomy surgery
- Expected survival time over 12 weeks
- ECOG performance status 0 to 2
- Willing to provide blood, urine, and tissue samples for testing
- Adequate organ function including blood counts, liver and kidney function
- Able and willing to comply with study protocol and sign consent
You will not qualify if you...
- Other active primary cancers except stable, treated prior malignancies
- Bilateral upper tract urothelial carcinoma
- Urothelial carcinoma in bladder except completely resected non-muscle-invasive bladder cancer
- Live attenuated vaccine within 4 weeks before or planned during study
- Active or suspected autoimmune disease
- History of primary immunodeficiency
- History of organ or stem cell transplantation
- Pregnant or breastfeeding females
- Untreated active Hepatitis B or C infection
- Immunosuppressive medication within 4 weeks before treatment except low-dose steroids
- Allergy to Tislelizumab or Nab-Paclitaxel
- Active tuberculosis
- Prior treatment with immune checkpoint inhibitors
- Participation in another clinical study
- Fertile men or women without effective contraception
- Uncontrolled illnesses such as HIV, severe infections, psychiatric or neurological disorders, unstable respiratory or cardiovascular disease, active bleeding or thrombotic disease, or severe kidney failure requiring dialysis
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 9 weeks
Participants receive neoadjuvant therapy with Tislelizumab and Nab-Paclitaxel administered intravenously every 3 weeks for 2 to 3 cycles.
2 to 3 visits every 3 weeks (in-person)
Duration - Up to 2 weeks
Participants undergo radical nephroureterectomy surgery following completion of neoadjuvant therapy.
1 surgery visit and immediate post-operative care
Duration - Up to 5 years
Participants are monitored for treatment-related adverse events and survival outcomes for up to 5 years after surgery.
Follow-up visits as scheduled for up to 5 years
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
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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