Actively Recruiting
Combination of DV and Tislelizumab for Renal Preservation in High-risk UTUC Patients
Led by RenJi Hospital · Updated on 2025-12-09
20
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
T
Tianjin Medical University Second Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, open, multiple-center clinical study of renal preservation therapy in high-risk upper urinary tract urothelial carcinoma patients . The study was conducted in accordance with the Good Practice for Quality Control of Clinical Trials for Pharmaceutical Products (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (2.0 mg/kg intravenously every 3 weeks) combined with Tislelizumab (200mg intravenously every 3 weeks).
CONDITIONS
Official Title
Combination of DV and Tislelizumab for Renal Preservation in High-risk UTUC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status between 0 and 2
- HER-2 immunohistochemistry score between 0 and 3+
- Underwent cystoscopic or ureteroscopic biopsy, exfoliation cytology, and CT or MRI diagnosis
- Diagnosed with high-risk upper urinary tract urothelial carcinoma based on risk factors such as hydronephrosis, tumor diameter 2 cm, high-grade tumor, multiple tumors on cytology, previous radical cystectomy for high-grade bladder cancer, or biopsy pathology showing other tissue components
- Tumors classified as renal pelvic (cT1-T3, N0) or ureteral (cT1-T3, N0-N1) without distant metastasis (M0)
- Candidates for absolute or relative kidney preservation, including those with only one kidney or renal insufficiency (eGFR < 60 ml/min)
- Desire to protect the kidney
- Strong desire to preserve the kidney even without indication for kidney preservation
- Agree to provide biopsy tissue specimens and reserve pre-treatment blood, urine, and biopsy biological samples
- Predicted survival of at least 3 months
- Normal major organ function within 14 days before enrollment
- International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) 1.5 times upper limit of normal for patients not on anticoagulants; patients on anticoagulants must keep therapeutic levels
- No systemic corticosteroid medication within 4 weeks prior to treatment
- Fertile men or women at risk of pregnancy must use effective contraception during the trial and for 12 months after treatment
- Voluntarily consent to participate with good compliance and cooperation with follow-up
You will not qualify if you...
- Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 therapies
- Known allergy to recombinant humanized anti-PD-1 monoclonal antibodies or their components
- Received other antitumor therapies or participated in other clinical trials within 4 weeks prior to study treatment, or unresolved toxicity from previous treatments (except mild hair loss or neurotoxicity)
- Pregnant or lactating women
- Positive HIV test
- Active hepatitis B or C infection
- Positive HBV DNA in patients with certain hepatitis B markers
- Positive HCV antibodies with detectable HCV RNA
- History of active tuberculosis
- Active autoimmune diseases requiring systemic treatment within the past 2 years
- Serious uncontrolled diseases including severe infections, uncontrolled diabetes, cardiovascular or pulmonary diseases
- Received live vaccine within 4 weeks before treatment start
- Previous allogeneic hematopoietic stem cell or solid organ transplant
- Major surgery (other than diagnostic) within 4 weeks prior to treatment
- History of psychotropic drug abuse or untreated mental disorders
- Large symptomatic pleural effusion or ascites needing treatment
- Other unhealed malignancies within 5 years except certain low-risk cancers
- Muscle-invasive bladder cancer
- Other severe medical or psychiatric conditions or lab abnormalities that increase risk or interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ethics Committee of Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
jiwei huang
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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