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New drug duo aims to fight kidney cancer without losing the kidney
NCT ID NCT07584733
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a two-drug treatment (disitamab vedotin plus tislelizumab) for people with a rare, aggressive cancer of the upper urinary tract that has a specific marker (HER2-positive). The goal is to shrink the tumor so that the kidney can be saved, avoiding complete removal. About 50 adults will receive the drugs before deciding on surgery, with the main focus on keeping the kidney cancer-free for at least one year.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ethics Committee of Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China
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