NCT06598761

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective cohort study. 1. Observation group: patients in the observation group were T3-4,N+ pyeloureteral cancer patients who did not tolerate chemotherapy or refused chemotherapy after radical surgery. No treatment will be given after surgery, and regular review will be conducted. 2. Postoperative immunotherapy+radiotherapy group: Adjuvant immunotherapy: the immunotherapy drug choice is tirilizumab, which has been recommended in metastatic uroepithelial cancer in China. Tirelizumab 200mg Q3w; the duration of immunotherapy is recommended to be used 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) technique is used. Irradiation range: Renal pelvis and upper ureter: ipsilateral renal fossa, para-abdominal aorta (including upper ureteral alignment area), common iliac lymph node area; Middle and lower ureteral carcinoma: parabasal abdominal aorta (renal hilar vessels and following levels), common iliac lymph node area (right side needs to include paraventricular lymph node area) + internal and external iliac lymph node area + middle and lower ureteral alignment area, entrance of the ureteral bladder. Radiotherapy dose: 45-50Gy/25f/5w, 62.5Gy/25f/5w regimen was given to suspected metastatic lymph nodes visible on imaging. Ensure that normal tissue is within the dose limits. Note: The right tumour para-abdominal aortic lymph node drainage area needs to include: para vena cava + intervening vena cava + left para-abdominal aorta Left tumour para-abdominal lymph node drainage area needs to include: intervening vena cava + left para-abdominal aorta

Conditions

• Ureter Cancer
• Renal Pelvic Carcinoma
• Advanced Urothelial Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2026-12-31
• Completion: 2027-08-30
• First posted: 2024-09-19
• Last updated: 2024-11-05

Locations

2 sites across 1 country: China