Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Upper Tract Urothelial Carcinoma | Renal Pelvis and Ureter Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| Disitamab Vedotin (RC48) | Drug | Disitamab Vedotin | ALIAS |
| Gemcitabine (1000 mg/m2) | Drug | Gemcitabine | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Disitamab Vedotin Plus Radiotherapy
- description
- 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.
- interventionNames
- Drug: Disitamab Vedotin (RC48)
- Radiation: radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine Plus Carboplatin
- description
- Participants in this arm will receive gemcitabine plus carboplatin as adjuvant treatment after radical surgery for HER2-expressing cisplatin-ineligible upper tract urothelial carcinoma.
- interventionNames
- Drug: Gemcitabine (1000 mg/m2)
- Drug: carboplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available