Actively Recruiting
Perioperative Disitamab Vedotin and Tislelizumab Followed by Nephron-Sparing Surgery in High-Risk Upper Tract Urothelial Carcinoma: A Phase 2 Trial (DISTINCT-I)
Led by RenJi Hospital · Updated on 2025-12-09
20
Participants Needed
1
Research Sites
60 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
Researchers are evaluating a combination treatment of RC48 and Tislelizumab for patients with high-risk upper urinary tract urothelial carcinoma who are seeking kidney preservation. This Phase 2 clinical study aims to assess the safety and effectiveness of this therapy in helping preserve kidney function while treating the cancer. The study follows strict clinical trial quality standards and will enroll about 20 participants. The treatment involves intravenous administration of RC48 at a dose of 2.0 mg/kg every three weeks and Tislelizumab at 200 mg every three weeks. Both drugs are given by intravenous drip over one hour, starting on day 1 of the first 21-day cycle. Participants will receive this combined therapy before undergoing nephron-sparing surgery, aiming to protect kidney function while treating the tumor. During the study, participants will be closely monitored for kidney-intact event-free survival up to one year, along with clinical responses before and after surgery, disease-free survival, and rates of adverse events over two years. Kidney function preservation will be tracked for one year. Participants will provide biopsy tissue and biological samples, and undergo imaging and laboratory tests. The study includes follow-up assessments to evaluate treatment outcomes and safety over time, with total participation lasting up to two years.
CONDITIONS
Brief 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 0 to 2
- HER-2 IHC score between 0 and 3+
- Diagnosis confirmed by cystoscopic/ureteroscopic biopsy, exfoliation cytology, and CT or MRI
- High-risk upper urinary tract urothelial carcinoma with risk factors such as hydronephrosis, tumor diameter ≥2 cm, high-grade tumor, multiple tumors in cytology, prior radical cystectomy for high-grade bladder cancer, or biopsy showing other tissue components
- Tumors including renal pelvic tumors (cT1-T3, N0) or ureteral tumors (cT1-T3, N0-N1) with no distant metastasis (M0)
- Indications for absolute or relative kidney preservation (single kidney or renal insufficiency with eGFR < 60 ml/min)
- Desire to preserve the kidney
- Agreement to provide biopsy tissue specimens and reserve pre-treatment blood, urine, and biopsied biological samples
- Predicted survival of at least 3 months
- Normal major organ function within 14 days prior to enrollment
- INR and aPTT ≤1.5 times the upper limit of normal for patients not on anticoagulants; those on anticoagulants must maintain therapeutic levels
- No systemic corticosteroid use within 4 weeks prior to treatment
- Fertile men or women must use effective contraception during the trial and for 12 months after
- Voluntary informed consent, good compliance, and willingness to cooperate 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
- Other antitumor therapies or clinical trial participation within 4 weeks prior to study treatment, or unresolved toxicity from prior treatments (except certain hair loss or neurotoxicity)
- Pregnant or breastfeeding women
- Positive HIV test
- Active hepatitis B or C infection or positive HBV DNA above study limits
- Positive HCV antibodies with positive HCV RNA PCR
- History of active tuberculosis
- Active autoimmune diseases requiring systemic treatment within the past 2 years
- Serious uncontrolled diseases including severe infections, uncontrolled diabetes, advanced cardiovascular or pulmonary disease
- Live vaccine within 4 weeks prior to treatment
- History of allogeneic stem cell or organ transplantation
- Major surgery within 4 weeks prior to treatment
- History of psychotropic drug abuse or mental disorders
- Large symptomatic pleural effusion or ascites
- Other unhealed malignancies in past 5 years except certain cured or low-risk cancers
- Muscle-invasive bladder cancer
- Other severe acute or chronic medical or psychiatric conditions that increase risks or interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Several 21-day cycles until surgery
Participants receive disitamab vedotin and tislelizumab administered intravenously every 3 weeks as part of the treatment regimen before nephron-sparing surgery.
Visits every 3 weeks for drug administration
Duration - 1 day
Participants undergo nephron-sparing surgery following the perioperative drug treatment.
1 surgical visit (in-patient)
Duration - Up to 2 years
Participants are monitored for kidney-intact event-free survival, clinical response, disease-free survival, adverse events, and renal function preservation after surgery and treatment.
Visits at 3 months before surgery, 4 months after surgery, and regular follow-up visits up to 2 years
Trial Site Locations
Total: 1 location
1
Ethics Committee of Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
jiwei huang
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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