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RECRUITING
NCT06598761

Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUC

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

Summary

This is a prospective cohort study to analyse the safety and efficacy of postoperative adjuvant radiotherapy combined with immunotherapy versus surgery alone group of UTUC patients with T3-4 stages or lymph nodes metastasis(N+) status.

Official title: Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced Upper Tract Urothelial Carcinoma: a Prospective Observational Cohort Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2022-01-01

Completion Date

2027-08-30

Last Updated

2024-11-05

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Immunotherapy+radiotherapy

Adjuvant Immunotherapy: Immunotherapy drug of choice is tirilizumab, which has received national recommendations in metastatic uroepithelial cancer. Tirelizumab 200mg Q3w; the duration of immunotherapy is recommended for at least 1 year. Adjuvant radiotherapy can be given concurrently or sequentially with adjuvant immunotherapy; it is recommended that radiotherapy can be started within 4-6 weeks after surgery. Rotational intensity-modulated radiotherapy (VMAT), daily image-guided radiotherapy (Daily IGRT) techniques are used.

OTHER

surveillance alone

Patients recieve surveillance alone without any adjuvant interventions until any disease progression endpoints occur.

Locations (2)

Departmeng of Urology, Peking University First Hospital

Beijing, China

Department of Radiotherapy Oncology, Peking University First Hospital

Beijing, China