Actively Recruiting
Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced Upper Tract Urothelial Carcinoma: a Prospective Observational Cohort Study
Led by Peking University First Hospital · Updated on 2024-11-05
60
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have undergone radical nephroureterectomy with full-length removal and have pathologically confirmed renal pelvis or ureter cancer with stage pT3-4 or lymph node metastasis (pN+)
- Patients with creatinine clearance (eGFR) less than 60 ml/min or with underlying disease refusing or unable to tolerate chemotherapy
- Age between 18 and 80 years old
- Completed abdominopelvic CT scan within 4 weeks prior to enrollment
- No other malignant disease within the past 5 years except for non-melanoma skin cancer or ductal carcinoma in situ of the breast
- Willing to undergo necessary examinations and follow-up visits and provide written informed consent
- Expected survival over 6 months
- Karnofsky Performance Status (KPS) greater than 70
- Blood counts: leukocytes ≥ 3.5 x 10^9/l, neutrophils ≥ 1.5 x 10^9/l, platelets ≥ 100 x 10^9/l, hemoglobin ≥ 90 g/l
You will not qualify if you...
- Presence of distant metastases at the time of surgery or incomplete tumor removal (non-R0 resection)
- History of pelvic or abdominal radiotherapy
- History of systemic chemotherapy
- Pregnant or breastfeeding women, or women of childbearing potential not using reliable contraception
- History of other malignant tumors within last 5 years except for certain skin cancers and cervical cancer in situ
- Weight loss greater than 10% in the past 6 months
- Active infections or bleeding disorders
- Clinically significant heart disease such as unstable angina, congestive heart failure (NYHA class II or higher), unstable arrhythmia, or peripheral vascular disease (class II or higher)
- Psychological, family, or social factors preventing informed consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing after surgery
Participants who do not receive additional treatment after surgery are regularly monitored with follow-up visits to check their health status.
Regular follow-up visits
Duration - At least 1 year
Participants receive adjuvant immunotherapy with tirilizumab every 3 weeks for at least 1 year combined with radiotherapy starting within 4-6 weeks after surgery using advanced radiation techniques.
Immunotherapy every 3 weeks and daily radiotherapy for 5 weeks
Duration - After treatment completion until study end
Participants are monitored after completion of immunotherapy and radiotherapy to assess their health and detect any disease progression.
Regular follow-up visits
Trial Site Locations
Total: 2 locations
1
Departmeng of Urology, Peking University First Hospital
Beijing, China
Actively Recruiting
2
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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