Surgery Following Immune Checkpoint Inhibitions for Controlled Disease in Recurrent or Metastatic dMMR/MSI-H Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Disease-free Survival
研究概览
简要总结
Surgical resection for residual lesions could significantly improve the prognosis in metastatic colorectal cancers (CRCs) after systemic treatments, yet the necessity of resecting residual lesions after immune checkpoint inhibitions (ICIs) remains controversial in mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) diseases. We retrospectively enrolled recurrent or metastatic dMMR/MSI-H CRCs who received surgerys from Sun Yat-sen University Cancer Center. Patients without disease progression after at least 2 cycles of ICIs were included. Demographic and clinicopathological data were collected and analyzed. Relapse-free survival (RFS) after surgery were analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically confirmed CRC with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)20;
- •definite pathological or radiological evidence of recurrent or distant metastasis;
- •received at least 2 courses of ICIs;
- •confirmed as dMMR by immunohistochemical method or MSI-H by polymerase chain reaction or next-generation sequencing;
- •receiving therapeutic surgical treatment for residual lesions or tumor sites and achieving no evidence of disease (NED) ;
- •no progression within the duration of preoperative ICIs
排除标准
- 未提供
结局指标
主要结局
Disease-free Survival
时间窗: up to 5 years
defined as the time from randomization to the first appearance of one of the following: primary tumor recurrence, or death without cancer event; or censored at date of last follow-up
Overall Survival
时间窗: up to 5 years
defined as the time from randomization to death from any cause. Participants who were alive or lost to follow-up at the time of the analysis were censored at the date they were last known to be alive
次要结局
未报告次要终点
研究者
Pei-Rong Ding
MD, Ph D
Sun Yat-sen University