Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Metastatic Urothelial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic urothelial carcinoma.
详细描述
This is a multi-center single-arm translational study where patients with mUC who are about to receive pre-determined IO-based anti-tumor therapy will be invited to participate the study. After signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study via GS-MS/MS and/or LC-MS/MS to identify potential metabolite and protein markers that are able to predict efficacy and side effects of IO-based therapies. All subjects in the first-line, maintenance after 1st line, second-line, or subsequent lines of IO-based therapy will be invited and recruited, but those who have received any IO-based therapy before the study can NOT be recruited.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age > 20 years
- •Subjects diagnosed as metastatic urothelial carcinoma (mUC)
- •Subjects who are about to receive IO-based therapy
- •ECOG performance 0, 1, 2, and 3
- •Life expectancy 3 months
- •eGFR > 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
- •Willing to sign the informed consent form
排除标准
- •Subjects NOT willing to sign the informed consent form
- •Subjects with active infection or active urinary tract infection, as shown by urinary WBC > 5/HPF
- •Subjects having co-existing other malignancies that need active treatment. Those with other malignancies that do not need active treatment are allowed to join the study.
- •Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
- •Subjects who have taken any CPIs before. However, subjects who have received intravesical or intrapelvic BCG instillation are allowed to enroll.
- •Subjects who have received anti-FGFR therapy, enfortumab vedotin or other systemic therapies within 12 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for >12 weeks are allowed to enroll. Subjects who have received or are receiving cytotoxic chemotherapy are allowed to join the study.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 7 years
Duration of response (DOR)
时间窗: 7 years
Overall survival (OS)
时间窗: 7 years
Objective Response Rate (ORR)
时间窗: 7 years
Adverse event of special interest (AESI)
时间窗: 7 years
次要结局
未报告次要终点