Zhongshan Hospital，Fudan University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 653
- 主要终点
- PFS
研究概览
简要总结
A single biomarker is not adequate to identify patients with colorectal cancer (CRC) who have the potential to benefit from adjuvant therapy, presumably owing to the complexity of tumor-infiltrating immune cells (TIICs). The density and spatial organization of TIICs has not been definitely established to explore their predictive value. This study aimed to investigate the prognostic significance of TIICs and its biological predictive value in CRC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign a written ICF.
- •The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or
- •The expected survival period is ≥ 3 months.
- •Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.
- •Colorectal cancer patients who have not received systematic anti-tumor therapy in the past.
排除标准
- •Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).
- •Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.
- •Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration
结局指标
主要结局
PFS
时间窗: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
次要结局
未报告次要终点
研究者
Xu jianmin
Head of colorectal surgery department, Principal Investigator, Clinical Professor, Zhongshan Hospital
Fudan University