Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
A Randomized, Prospective, Multicenter, Phase III Study of Disitamab Vedotin Plus Radiotherapy as Adjuvant Treatment for HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
- Upper Tract Urothelial Carcinoma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Peking University First Hospital
- Enrolment target
- 192
- Started
- 1 May 2026
- Main results due
- 1 May 2029
- Study sites
- 1
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Aged 18 years or older. * Histologically confirmed upper tract urothelial carcinoma (UTUC) after radical nephroureterectomy (RNU). * Postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0. * HER2 expression confirmed by immunohistochemistry (IHC 1+, 2+, or 3+). * Cisplatin-ineligible, defined as meeting at least one of the following criteria: ECOG performance status 2; creatinine clearance \<60 mL/min; CTCAE grade 2 or higher hearing loss; CTCAE grade 2 or higher peripheral neuropathy; or New York Heart Association (NYHA) class III heart failure. * Adequate organ function. * Expected survival of at least 6 months. Exclusion Criteria: * History of other active malignancies, except for adequately treated malignancies with low risk of recurrence. * Prior systemic antitumor therapy before study treatment, or unresolved toxicities from prior therapy. * Known hypersensitivity to disitamab vedotin, related agents, or any component of the study treatment. * Severe active infection. * Not adequately recovered from surgery. * Pregnant or breastfeeding women. * Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
What this study is about
In the sponsor’s own words, from the registry.
This randomized, open-label, multicenter phase III study is designed to compare disitamab vedotin plus radiotherapy with gemcitabine plus carboplatin as adjuvant treatment in patients with HER2-expressing upper tract urothelial carcinoma after radical nephroureterectomy (RNU). Eligible patients must have postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0, HER2 expression defined as immunohistochemistry (IHC) 1+, 2+, or 3+, and be cisplatin-ineligible. Patients will be randomized in a 2:1 ratio to receive disitamab vedotin plus radiotherapy or gemcitabine plus carboplatin. The primary endpoint is 3-year disease-free survival. Secondary endpoints include overall survival, metastasis-free survival, local recurrence-free survival, bladder recurrence-free survival, incidence of adverse events, and patient-reported quality of life.
Study sites(1)
Peking University First Hospital
Beijing, China
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07498907. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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