Disitamab Vedotin Plus Radiotherapy for HER2-Expressing Upper Tract Urothelial Carcinoma After Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, randomized, open-label, multicenter trial comparing disitamab vedotin plus radiotherapy versus gemcitabine plus carboplatin as adjuvant therapy after radical nephroureterectomy in patients with HER2-expressing UTUC. Eligible participants must have post-surgical high-risk disease (pT3-pT4N0M0 or pTanyN+M0), HER2 IHC 1+/2+/3+, and be cisplatin-ineligible. Randomization is 2:1 in favor of the disitamab vedotin plus radiotherapy arm. Primary endpoint is 3-year disease-free survival; secondary endpoints include overall survival, metastasis-free survival, local/bladder recurrence-free survival, adverse events, and quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Xuesong Li, Dr.
• Email: pineneedle@sina.com
• Phone: 010-83572418

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.