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NCT07504939

Multimodal Kidney-Sparing Strategy for High-Risk Upper Tract Urothelial Carcinoma

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

Summary

UTUC is a cancer that develops in the lining of the kidney or ureter. The standard treatment is radical nephroureterectomy, which removes the kidney and ureter. Although this surgery can control the cancer, it permanently reduces kidney function. Endoscopic treatment can serve as a kidney-sparing approach for low-risk UTUC; however, in high-risk patients, the high rate of upper tract local recurrence after endoscopic treatment remains the primary failure pattern. This study aims to evaluate the efficacy and safety of radiotherapy-involved kidney-sparing treatment for UTUC. The main questions this study aims to answer are: Can this multimodal kidney-sparing strategy reduce local recurrence of UTUC compared with endoscopic treatment alone? Participants in the kidney-sparing group will: Undergo endoscopic surgery to remove the tumor; Receive systemic therapy with disitamab vedotin and toripalimab; Receive targeted radiotherapy after surgery. Participants will undergo regular follow-up visits, including imaging examinations and endoscopic evaluations, to monitor for recurrence or disease progression. The results of this study may help determine whether a multimodal kidney-sparing treatment strategy could become a safe and effective option for selected patients with high-risk UTUC.

Official title: Evaluating a Kidney-sparing Strategy Combining Endoscopic Surgery, Adjuvant Radiotherapy, and HER2-targeted Antibody-Drug Conjugate in High-risk Upper Tract Urothelial Carcinoma: Study Protocol for a Prospective, Multicenter, Non-randomized Comparative Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

36

Start Date

2026-04-01

Completion Date

2030-04-01

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

RADIATION

SBRT

Participants without confirmed complete tumor resection will receive selective hypofractionated radiotherapy approximately one month after surgery.

Locations (1)

Departmeng of Urology, Peking University First Hospital

Beijing, China