NCT07584733Not yet recruitingPhase 2
Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper Tract Urothelial Carcinoma
A Prospective, Multicentre, Single-Arm Phase II Study Evaluating a Response-Adapted Kidney-Preserving Strategy Using Neoadjuvant Disitamab Vedotin Plus Tislelizumab in Patients With HER2-Positive High-Risk Upper Tract Urothelial Carcinoma (DISTINCT-II)
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
This is a prospective, multicentre, single-arm phase II study evaluating a response-adapted kidney-preserving strategy in patients with HER2-positive high-risk upper tract urothelial carcinoma (UTUC). Patients will receive neoadjuvant disitamab vedotin plus tislelizumab, followed by response-adapted local treatment, including kidney-sparing surgery or radical nephroureterectomy based on predefined criteria. The primary objective is to assess whether this multimodal strategy can achieve clinically meaningful oncologic control while preserving renal function, as measured by 1-year kidney-intact event-free survival (KI-EFS). Secondary and exploratory objectives include evaluation of clinical response, survival outcomes, safety, renal function preservation, and longitudinal dynamics of circulating and urinary tumor DNA.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 4 May 2026
- Start date
- 31 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT07584733
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 31 May 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic therapy for urothelial carcinoma, including:Chemotherapy; Immunotherapy; HER2-targeted therapy.
- Prior radical nephroureterectomy for current disease.
- Current use of immunosuppressive medication, excluding physiologic doses of corticosteroids.
Other illness
- Evidence of distant metastatic disease (M1).
- Unresectable or bulky nodal disease (≥N2) not amenable to curative-intent surgery.
- Active autoimmune disease requiring systemic treatment within the past 2 years.
- Uncontrolled intercurrent illness, including but not limited to: Active infection requiring systemic therapy; Uncontrolled cardiovascular disease; Significant pulmonary disease
- Known active hepatitis B, hepatitis C, or HIV infection with uncontrolled viral replication.
- History of another malignancy within the past 5 years, except: Adequately treated basal cell carcinoma; Squamous cell skin cancer; In situ carcinoma.
- Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- Age ≥18 years at the time of informed consent.
- Histologically confirmed upper tract urothelial carcinoma (UTUC) arising from the renal pelvis or ureter, based on ureteroscopic biopsy.
- High-risk UTUC, defined by at least one of the following features: Tumour size ≥2 cm; High-grade cytology or biopsy; Radiographic evidence of local invasion (≥cT2); Hydronephrosis; Multifocal disease
- Clinical stage cT1-T3, N0-N1, M0, based on radiographic assessment.
- N1 disease is permitted only if lymph nodes are considered resectable.
- HER2-positive disease, defined as immunohistochemistry (IHC) score of 1+，2+ or 3+ on tumour tissue, assessed according to predefined criteria.
- At least one measurable lesion according to RECIST version 1.1.
- ECOG performance status of 0-1
- Adequate organ function, including: Hematologic function; Hepatic function; Renal function (no strict upper/lower limit required);
- Patients must be considered potential candidates for a kidney-preserving treatment strategy, including: Absolute or relative indication for renal preservation (e.g., solitary kidney, baseline renal insufficiency), or Strong preference for kidney preservation after multidisciplinary discussion
- Ability to understand and willingness to sign written informed consent.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ethics Committee of Shanghai Renji Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.