Comparing Postoperative Immunotherapy Plus Radiotherapy to Surgery Alone in Advanced Upper Tract Urothelial Carcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of adding postoperative adjuvant radiotherapy combined with immunotherapy compared to surgery alone in patients with locally advanced upper tract urothelial carcinoma UTUC who have T3-4 stage tumors or lymph node metastasis. This prospective cohort study focuses on patients who either cannot tolerate chemotherapy or choose not to receive it after radical surgery, aiming to improve outcomes in this challenging group. The study involves two groups an observation group receiving no additional treatment after surgery but undergoing regular check-ups, and a treatment group receiving adjuvant immunotherapy with tirilizumab at 200 mg every three weeks for at least one year. Radiotherapy, delivered via rotational intensity-modulated radiotherapy VMAT and daily image-guided radiotherapy Daily IGRT, can be given concurrently or sequentially starting within 4 to 6 weeks post-surgery. Radiation targets specific lymph node areas depending on tumor location, with doses ranging from 45 to 62.5 Gy over five weeks. Participants will be monitored regularly with imaging and clinical evaluations to track disease-free survival at one and three years, as well as overall survival and cancer-specific survival. The study includes assessments of kidney function and blood counts to ensure safety. The follow-up period extends up to three years to evaluate long-term outcomes and the impact of combined immunotherapy and radiotherapy compared to surgery alone.

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