Actively Recruiting
Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUC
Led by Peking University First Hospital · Updated on 2024-11-05
60
Participants Needed
2
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 had radical nephroureterectomy with pathologically confirmed renal pelvis or ureter cancer at stage pT3-4 or with lymph node metastasis (pN+)
- Patients with creatinine eGFR less than 60 ml/min or underlying disease refusing or unable to tolerate chemotherapy
- Aged between 18 and 80 years old
- Completed abdominopelvic CT scan within 4 weeks before enrollment
- No other malignant diseases except non-melanoma skin cancer or breast ductal carcinoma in situ within the last 5 years
- Willing to undergo necessary exams and follow-up visits and provide written informed consent
- Expected survival greater than 6 months
- Karnofsky Performance Status (KPS) over 70 points
- Leukocytes count at least 3.5 x 10^9/l
- Neutrophils count at least 1.5 x 10^9/l
- Platelets count at least 100 x 10^9/l
- Hemoglobin level at least 90 g/l
You will not qualify if you...
- Patients with distant metastases found at the time of surgery or non-R0 resection
- History of pelvic or abdominal radiotherapy
- History of inflammatory bowel disease
- History of systemic chemotherapy
- Pregnant or breastfeeding women, or women of childbearing potential not using reliable contraception
- History of malignant tumors except for non-melanoma skin cancer or cervical cancer in situ cured over 5 years ago
- Weight loss greater than 10% within 6 months
- Presence of active infections or bleeding disorders
- Clinically significant heart disease such as controlled hypertension, unstable angina, 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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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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