Clinical Trial

Neoadjuvant Disitamab Vedotin, Toripalimab, and Radiotherapy for High-risk UTUC ( LUXUS07.1 )

Study acronym: LUXUS0701
Not Yet Recruiting Phase 2
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Summary
This is an open-label, single-arm, single-cohort, prospective clinical study evaluating neoadjuvant antibody-drug conjugate therapy combined with immunotherapy and sequential radiotherapy followed by radical surgery in patients with high-risk upper tract urothelial carcinoma (UTUC). Eligible patients will receive neoadjuvant disitamab vedotin (RC48) plus toripalimab, followed by response-guided neoadjuvant radiotherapy and radical nephroureterectomy with bladder cuff excision. The study will assess the safety, feasibility, and preliminary antitumor activity of this multimodal neoadjuvant strategy, with pathological complete response rate as the primary endpoint.
Trial Details
NCT Number NCT07720921
Lead Sponsor Peking University First Hospital
Conditions Urothelial Carcinoma of the Renal Pelvis and Ureter, Neoadjuvant Therapy
Enrollment 20 participants
Start Date 2026-08-01
Primary Completion 2027-08-01 (estimated)
Study Completion 2029-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-22