Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced Upper Tract Urothelial Carcinoma: a Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- DFS
研究概览
简要总结
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.
详细描述
This study is a prospective cohort study.
- 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.
- 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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
结局指标
主要结局
DFS
时间窗: 1-year and 3-year
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.)
次要结局
- CSS(1-year and 3-year)
- OS(1-year and 3-year)