New combo therapy aims to save kidneys in High-Risk cancer patients
NCT ID NCT07504939
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a kidney-sparing approach for people with high-risk upper tract urothelial carcinoma, a cancer in the kidney or ureter. Instead of removing the whole kidney, participants get endoscopic surgery, targeted radiotherapy, and two drugs (disitamab vedotin and toripalimab). The goal is to see if this combination can prevent the cancer from coming back while keeping the kidney working. The trial plans to enroll 36 adults with HER2-positive tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- disitamab vedotin and toripalimab
- What this could lead to
- If successful, this could offer a way to treat high-risk upper tract urothelial carcinoma without removing the kidney, preserving kidney function while controlling the cancer.
- What could go wrong
- This is a small, early-phase study with only 36 participants, so results may not apply broadly. The combination of treatments may cause side effects, and the cancer could still return.
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.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2030
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.
Who is studied
Patients with clinically histologically confirmed high-risk upper tract urothelial carcinoma who are evaluated and treated at Peking University First Hospital and participating centers will be screened for eligibility. Participants who meet the inclusion criteria and provide informed consent will be enrolled in the kidney-sparing treatment cohort or the radical nephroureterectomy cohort according to clinical decision-making and treatment preference.
- Ages
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18 years and older
- 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 Participants must meet all of the following criteria: Age 18 years or older Voluntary participation with written informed consent Pathology indicating upper tract urothelial carcinoma with HER2 at least 1+ expression Clinical stage cT1-T2N0M0 based on imaging evaluation Classified as high-risk upper tract urothelial carcinoma according to European Association of Urology (EAU) criteria Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Adequate renal function with split renal function of the affected kidney ≥10 mL/min on renal dynamic scintigraphy Expected life expectancy greater than 24 months Ability and willingness to comply with study procedures and follow-up schedule Exclusion Criteria Participants will be excluded if any of the following conditions are present: Inability to tolerate or refusal of kidney-sparing treatment Evidence of advanced disease (≥T3), lymph node metastasis, or distant metastasis Synchronous bladder urothelial carcinoma or other urological malignancies Previous systemic anticancer therapy, including chemotherapy, targeted therapy, immunotherapy, or antibody-drug conjugates Prior radiotherapy involving the urinary tract or retroperitoneal region Severe uncontrolled comorbidities such as cardiovascular, pulmonary, neurological, psychiatric, or systemic diseases Active severe infections requiring systemic antimicrobial therapy Known immune-related disorders requiring long-term immunosuppressive treatment Pregnancy or breastfeeding Known allergy to investigational drugs used in this study Concurrent participation in another therapeutic clinical trial Indeterminate postoperative pathological diagnosis
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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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Departmeng of Urology, Peking University First Hospital
Beijing, China
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