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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.
This study is a prospective cohort study.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation cohort | Patients in the observation group were T3-4 or N+ UTUC patients who were intolerant to chemotherapy or refused chemotherapy after radical surgery. No postoperative treatment was performed, and the patients were regularly rechecked. |
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| Postoperative 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy+radiotherapy | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| DFS | Disease-free survival,The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.) | 1-year and 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival,the time from randomization to the date of death from any cause | 1-year and 3-year |
| CSS | Cancer-specific survival,the time from randomization to the date of death due to disease (urothelial cancer). |
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Inclusion Criteria:
3)18≤age≤80 years old; 4)Completion of abdominopelvic CT 4 weeks prior to enrolment. 5)Except for cutaneous non-melanoma and ductal carcinoma in situ of the breast, the patient has not suffered from any other malignant disease within the last 5 years; 6)Willing to participate in perfecting the necessary examinations and follow-up visits for the sake of the study, and willing to provide written informed consent.
All of the above need to be fulfilled:
Expected survival > 6 months; KPS > 70 points; Leukocytes ≥ 3.5 x 109/l,Neutrophils ≥ 1.5 x 109/l, Platelets ≥ 100.0 x 109/l, Haemoglobin ≥ 90g/l.
Exclusion Criteria:
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All pT3-4/N+ UTUC patients who were eligible for enrolment and signed the informed consent could be included in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departmeng of Urology, Peking University First Hospital | Recruiting | Beijing | China |
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| surveillance alone | Other | Patients recieve surveillance alone without any adjuvant interventions until any disease progression endpoints occur. |
|
| 1-year and 3-year |
| Department of Radiotherapy Oncology, Peking University First Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D014516 | Ureteral Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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