Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligiblā¦ (NCT07498907) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
China192 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.