This randomized, open-label, multicenter phase II 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.
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+).
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.
Peking University First Hospital
Lead sponsor
RemeGen Co., Ltd.
Collaborator