Actively Recruiting
Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC)
Led by Tianjin Medical University Second Hospital · Updated on 2025-12-31
21
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neoadjuvant chemotherapy treatment can be used for specific UTUC patients, especially for highly staged and/or grade tumors, such as kidneys with potentially decreased renal function after RNU. Neoadjuvant therapy is a series of treatments administered preoperatively for UTUC, mainly chemotherapy, and in recent years, novel therapies of immunotherapy have emerged. Since conventional cisplatin neoadjuvant regimens also require high preoperative renal function, neoadjuvant therapy regimens such as immunotherapy provide more effective and feasible treatments for patients who are intolerant to current cisplatin chemotherapy regimens. The aim of this study was to explore the efficacy and safety of the combination of disitamab vedotin, a human epidermal growth factor receptor-2 (HER-2) targeted ADC, and tislelizumab, a humanised PD-1 ICIs, as neoadjuvant treatment for non-metastatic, high-risk, HER-2 expressing UTUC. In our study, patients enrolled will receive neoadjuvant tislelizumab plus disitamab-vedotin therapy followed by radical nephroureterectomy (RNU), distal ureterectomy (DU) or ureteroscopic ablation (UA) .
CONDITIONS
Official Title
Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed localized HER-2 expressing upper urothelial carcinoma (cT1-4N0-2M0) with high-risk disease
- Planned surgery: radical nephroureterectomy, distal ureterectomy, or ureteroscopic ablation
- Male or female aged 18 years or older
- Expected survival time greater than 12 weeks
- ECOG performance status score of 0 to 2
- Agree to provide blood, urine, and tissue samples for biomarker and molecular testing
- Adequate organ function including neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 80 x 10^9/L, hemoglobin ≥ 6.0 g/dL
- Liver function with total bilirubin ≤ 1.5 times upper limit of normal and transaminases ≤ 2.5 times upper limit of normal
- Renal function with glomerular filtration rate ≥ 15 ml/min
- Voluntary participation with informed consent and ability to comply with follow-up
You will not qualify if you...
- Receiving live attenuated vaccines within 4 weeks before or during the study (except COVID-19 vaccine)
- Active, known or suspected autoimmune disease
- History of primary immunodeficiency
- History of allogeneic organ or hematopoietic stem cell transplantation
- Pregnancy or breastfeeding
- Untreated acute or chronic active hepatitis B or C infection
- Recent immunosuppressive drug use within 4 weeks before therapy initiation (except certain corticosteroids)
- Known allergy to tislelizumab or disitamab vedotin
- Active tuberculosis history
- Prior treatment with PD-1/PD-L1/CTLA-4 antibodies or other immunotherapy
- Participation in other clinical studies
- Men or women of reproductive potential not using reliable contraception
- Uncontrolled comorbidities including HIV infection, severe or uncontrolled infections, and unstable or uncompensated systemic diseases such as severe psychiatric, neurological, respiratory, cardiovascular, hepatic, renal disease, or uncontrolled hypertension
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Hospital of Tianjin Medical University
Tianjin, China
Actively Recruiting
Research Team
H
Hailong Hu, MD,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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