NCT06682247尚未招募不适用
A Real-world Study of Chidamide in Combination with PD-1/PD-L1 Antibodies and Anti-angiogenic Agents in the Treatment of Microsatellite Stable Advanced Colorectal Cancer
Feng Wang0 个研究点目标入组 200 人开始时间: 2024年11月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
This is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in Microsatellite Stable advanced colorectal cancer patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged≥18 years
- •Histology-confirmed metastatic CRC (mCRC);
- •At least one efficacy evaluation
- •Life expectancy of at least 3 months.
排除标准
- •Lack of follow-up data.
- •Chidamide stopped after less than two cycles.
- •Serious comorbidities that interfere with the efficacy or safety analysis
研究组 & 干预措施
chidamide + PD-1/PD-L1 inhibitors +Bevacizumab or tyrosine kinase inhibitors
干预措施: Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors (Drug)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: 2 years
次要结局
- Objective Response Rate（ORR）(2 years)
- Clinical Benefit Rate (CBR)(2 years)
- Disease Control Rate （DCR）(2 years)
- Overall survival (OS)(2 years)
研究者
Feng Wang
Sun Yat-sen University Cancer Center
Sun Yat-sen University
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