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Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma

RecruitingPhase 3Ages 18 Years - anyAllPeking University First Hospital
NCT07498907 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Disitamab Vedotin (RC48)
  • radiotherapy
  • Gemcitabine (1000 mg/m2)
  • carboplatin
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Where

1 site
Peking University First Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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