The Role of Chronic Inflammation in Modulating Targeted Therapy Efficacy and Predicting Treatment Outcomes in Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 698
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Cancer-derived inflammation attenuates the efficacy of adjuvant chemotherapy (CT) in postoperative or metastatic colorectal cancer (mCRC). However, its role in mCRC patients receiving first-line Bevacizumab combined with chemotherapy (Bev/CT) remains unknown. In this prospective observational study, three Bev/CT regimen cohorts (discovery cohort,n=249; Internal validation cohort: n=115; external validation cohort: n=159) and one CT regimen cohort (n=175) were enrolled. Overall survival served as the primary endpoint; clinical response and progression-free survival were secondary endpoints evaluated during follow-up. Investigators used the serum inflammation ratios to evaluate the association between systemic inflammation and clinical outcomes in Bev/CT- and CT-treated mCRC. Combined analysis of 12 cytokines (flow cytometry) and 92 immuno-oncology proteins (Olink) revealed Bev resistance mechanisms and prognosis-predictive biomarkers in Bev/CT treated 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of mCRC;
- •Aged over 18 years;
- •Must be able to receive the further treatment in the hospital.
排除标准
- •More than two types of malignancies;
- •Bacterial or virus infection within one month before diagnosis;
- •Taken anti-inflammatory drugs or other forms of chemotherapy before their diagnosis;
- •participants whose follow-up was interrupted three months ago without reaching any endpoint.
结局指标
主要结局
Overall survival (OS)
时间窗: From January 2018 to December 2024
OS is the time from initial diagnosis to death, or the last follow-up
次要结局
- Progression-free survival (PFS)(Form January 2018 to December 2024)