Safety and Efficacy of Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: An Ambispective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 3
- 主要终点
- PFS
研究概览
简要总结
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.
详细描述
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.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
Adjuvant radioimmunotherapy
Participants underwent adjuvant radioimmunotherapy
干预措施: Radiotherapy (Radiation)
Adjuvant radioimmunotherapy
Participants underwent adjuvant radioimmunotherapy
干预措施: Immunotherapy (Drug)
Adjuvant chemotherapy
Participants underwent radical total nephroureterectomy and adjuvant chemotherapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
PFS
时间窗: 1-year, 3-year and 5-year
Progression-free Survival
次要结局
- CSS(1-year, 3-year and 5-year)
- IRFS and CRFS(1-year, 3-year and 5-year)
- OS(1-year, 3-year and 5-year)
- LRFS(1-year, 3-year and 5-year)
- MFS(1-year, 3-year and 5-year)
研究者
Xuesong Li
Department of Urology
Peking University First Hospital