A Phase 3 interventional study of Disitamab Vedotin (RC48) and radiotherapy in Upper Tract Urothelial Carcinoma, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Peking University First Hospital · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Participants in this arm will receive disitamab vedotin plus radiotherapy as adjuvant treatment after radical surgery for HER2-expressing,cisplatin-ineligible upper tract urothelial carcinoma.
Drug: Disitamab Vedotin (RC48) · Radiation: radiotherapy
Participants in this arm will receive gemcitabine plus carboplatin as adjuvant treatment after radical surgery for HER2-expressing cisplatin-ineligible upper tract urothelial carcinoma.
Drug: Gemcitabine (1000 mg/m2) · Drug: carboplatin
Disitamab vedotin 2.0 mg/kg (maximum 120 mg) will be administered intravenously every 2 weeks for 12 cycles as adjuvant treatment after radical surgery.
Adjuvant radiotherapy will be delivered to the regional lymphatic drainage area at 45-50 Gy in 25 fractions over 5 weeks. Suspicious lymph nodes will receive 62.5 Gy in 25 fractions over 5 weeks.
Gemcitabine 1000 mg/m² will be administered on Days 1 and 8 of each 21-day cycle for 4 to 6 cycles as adjuvant treatment after radical surgery.
Carboplatin will be administered intravenously on Day 1 of each 21-day cycle at a target AUC of 4.5 to 5 for 4 to 6 cycles as adjuvant treatment after radical surgery.
3-Year Disease-Free Survival
Disease-free survival (DFS) is defined as the time from randomization to first recurrence in the tumor bed, first metastasis, or death from any cause, whichever occurs first.
Time frame: From randomization up to 3 years
Overall Survival
Overall survival (OS) is defined as the time from randomization to death from any cause.
Time frame: From randomization up to 3 years
Metastasis-Free Survival
Metastasis-free survival (MFS) is defined as the time from randomization to first documented distant metastasis or death from any cause, whichever occurs first.
Time frame: From randomization up to 3 years
Local Recurrence-Free Survival
Local recurrence-free survival (LRFS) is defined as the time from randomization to first documented locoregional recurrence in the tumor bed or regional lymph nodes, or death from any cause, whichever occurs first.
Time frame: From randomization up to 3 years
Bladder Recurrence-Free Survival
Bladder recurrence-free survival (BRFS) is defined as the time from randomization to first documented bladder urothelial recurrence or death from any cause, whichever occurs first
Time frame: From randomization up to 3 years
Incidence of Adverse Events
Safety will be evaluated based on the incidence, type, severity, and attribution of adverse events during study treatment and follow-up.
Time frame: From first dose through 30 days after completion of study treatment and up to 3 years for follow-up
Patient-Reported Quality of Life
Patient-reported quality of life will be assessed using validated quality-of-life questionnaires during treatment and follow-up.
Time frame: Baseline through 3 years
Plan to share: No
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Peking University First Hospital