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Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC

Recruitingn/aAges 18 Years - anyAllPeking University First Hospital
NCT06120374 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Confirmed pathologic diagnosis as upper urinary tract urothelial carcinoma(UTUC); * High-risk UTUC: \>= pT2, pN+, tumor G3 grade, multifocality or positive surgical margins (according to AJCC 8th edition); * Aged \>= 18 years old; Exclusion Criteria: * With Distant metastases already found at the time of surgery; non-R0 resected ; * History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; * Pregnant or lactating women; or women of childbearing potential who are not using reliable contraception; * History of malignant tumors (except skin cancer that is not malignant melanoma and in situ cervical cancer, tumors that have been cured for more than 5 years); * Weight loss \> 10% within 6 months; * Existing or coexisting bleeding disorders, active infection; * Terrible condition cannot tolerate the intervention; * Unable to sign informed consent due to psychological, family, social and other factors.
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What it tests

  • Radiotherapy
  • Chemotherapy
  • Immunotherapy
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Where

3 sites
Departmeng of Urology, Peking University First Hospital
Beijing, China
Department of Medical Oncology, Peking University First Hospital
Beijing, China
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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