Disitamab vedotin with radiotherapy after surgery for upper tract urothelial cancer
Compares disitamab vedotin with radiotherapy to chemotherapy after kidney and ureter surgery.
Plain-language title generated from the registry record
Registry title: Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University First Hospital
- Trial code
- NCT07498907
- Record updated
- 28 September 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Prospective, Multicenter, Phase III Study of Disitamab Vedotin Plus Radiotherapy as Adjuvant Treatment for HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
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.
Inclusion: 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: Prior systemic antitumor therapy before study treatment, or unresolved toxicities from prior therapy; Not adequately recovered from surgery; History of other active malignancies, except for adequately treated malignancies with low risk of recurrence; Known hypersensitivity to disitamab vedotin, related agents, or any component of the study treatment; Severe active infection; Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study; Pregnant or breastfeeding women.