postoperative adjuvant immunotherapy combined with radiotherapy versus surgery alone in locally advanced utuc

Conditions: Ureter Cancer; Renal Pelvic Carcinoma; Advanced Urothelial Carcinoma

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.

this study is a prospective cohort study. 1. observation group: patients in the observation group were t3-4,n+ pyeloureteral cancer patients who did not tolerate chemotherapy or refused chemotherapy after radical surgery. no treatment will be given after surgery, and regular review will be conducted. 2. postoperative immunotherapy+radiotherapy group: 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

Eligibility criteria:
inclusion criteria: * 1) patients after radical nephroureterectomy with full-length nephroureterectomy and pathologically confirmed cancer of the renal pelvis or ureter, ajcc staging (8th edition) containing one of the following factors: pt3-4, pn+; 2) patients with creatinine egfr \<60 min/l. or underlying disease refusing to tolerate chemotherapy. 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: * 1) distant metastases already found at the time of surgery; non-r0 resected patients 2) history of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; (3) pregnant or breastfeeding women; or women of childbearing potential who are not using reliable contraception; (4) history of malignant tumour (except skin cancer that is not malignant melanoma and cervical cancer in situ, tumours that have been cured for more than 5 years) 5) weight loss \> 10% within 6 months 6) presence of active infections in those with pre-existing or co-existing bleeding disorders 7) clinically significant cardiac disease (e.g., hypertension controlled by medication, unstable angina pectoris, new york heart association (nyha) class ≥ ii congestive heart failure, unstable symptomatic arrhythmia, or class ≥ ii peripheral vascular disease); 8) psychological, family, and social factors leading to lack of informed consent.

Keywords: upper tract urothelial carcinoma radiotherapy immunotherapy combined therapy prospective cohort study