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NCT07584733

PHASE2

Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper Tract Urothelial Carcinoma

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05-31

Completion Date

2028-12-31

Last Updated

2026-05-13

Healthy Volunteers

Conditions

Upper Tract Urothelial Carcinoma

Interventions

DRUG

RC48 Combined With Tislelizumab

In this trial, RC48 was scheduled to be administered at a dose of 2.0 mg/kg every 3 weeks, with the first dose on day 1 of the first cycle. Tislelizumab was administered at a dose of 200 mg every 3 weeks, with the first dose on day 1 of the first 21-day cycle. The drug is diluted with normal saline and administered by intravenous drip for one hour.

Inclusion Criteria: * 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. Exclusion Criteria: * Evidence of distant metastatic disease (M1). * Unresectable or bulky nodal disease (≥N2) not amenable to curative-intent surgery. * Prior systemic therapy for urothelial carcinoma, including:Chemotherapy; Immunotherapy; HER2-targeted therapy. * Prior radical nephroureterectomy for current disease. * Active autoimmune disease requiring systemic treatment within the past 2 years. * Current use of immunosuppressive medication, excluding physiologic doses of corticosteroids. * 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. * Pregnant or breastfeeding women. * Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results.

Locations (1)

Ethics Committee of Shanghai Renji Hospital

Shanghai, Shanghai Municipality, China