Efficacy , Safety, and Predictors of Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer in a Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- overall survival (OS)
研究概览
简要总结
The survival of the refractory CRC is dismal and therapy options are limited ，the researchers aim to investigate the efficacy, safety, and predictors of fruquintinib plus PD-1 in refractory MSS metastatic colorectal cancer in a real-world setting.
详细描述
The invesgators conducted a retrospective single arm, single-center study in which patients with MSS/pMMR mCRC were received fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022. Eligible patients were aged 18 years or older and had histologically or cytologically confirmed adenocarcinoma of the colon or rectum; with patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).The primary endpoint was overall survival (OS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with MSS/pMMR mCRC who have been received Fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022;
- •Eligible patients were aged 18 years or older
- •had histologically or cytologically confirmed adenocarcinoma of the colon or rectum;
- •patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).
- •an Eastern Cooperative Oncology Group performance status of 0-2;
排除标准
- •Pregnancy, lactating female or possibility of becoming pregnant during the study.
- •Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).
- •Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
- •Has severe or uncontrolled active acute or chronic infection. 5.Known carriers of HIV antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.
研究组 & 干预措施
study group
fruquintinib combined with anti-PD-1 antibodies
干预措施: Fruquintinib combined with anti-PD-1 antibodies (Drug)
结局指标
主要结局
overall survival (OS)
时间窗: assessed up to 2 year
Overall survival defined as the observed time from the treatment of the study until death due to any cause
次要结局
- progress-free survival (PFS)(assessed up to 1 year)