RecruitingNCT06598761

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


Sponsor

Peking University First Hospital

Enrollment

60 participants

Start Date

Jan 1, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding immunotherapy and radiation therapy after surgery can improve outcomes for patients with locally advanced upper urinary tract cancer (cancer in the kidney pelvis or ureter) compared to surgery alone. **You may be eligible if...** - You have had surgery (nephroureterectomy) to remove your kidney and ureter due to cancer - Your cancer was confirmed to be advanced (pT3-4 or involving lymph nodes) - You have kidney function issues or medical reasons preventing chemotherapy - You are between 18 and 80 years old - You are in good functional health (KPS above 70) **You may NOT be eligible if...** - Your cancer had already spread to distant organs at the time of surgery - The surgery did not remove all visible cancer - You have had prior pelvic or abdominal radiation, inflammatory bowel disease, or prior systemic chemotherapy - You are pregnant or breastfeeding - You have had another cancer in the past 5 years (with exceptions) - You have lost more than 10% of your body weight in the last 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTImmunotherapy+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.

OTHERsurveillance 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06598761


Related Trials