NCT07105631招募中不适用
Patient-reported Outcomes (PRO) and Treatment Outcomes of Chinese Patients With MSS-type Advanced Colorectal Cancer Who Received the Zidovudine Combination Regimen in the Real World: A Prospective, Multicenter, Observational Study Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Grade 3-4 adverse effects rate
研究概览
简要总结
The Chidamide + sintilimab ± bevacizumab regimen has become a post-treatment option for clinicians and patients after being included in the guidelines. The CAPability-01 study is a phase II RCT, with a limited number of enrolled subjects. Further observation of the safety and clinical real-world application status of the sidibemab combination regimen is needed in a larger sample size prospective observational cohort study. The primary endpoint of this study is the safety events of the sidibemab combination regimen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, gender not restricted;
- •Advanced colorectal cancer confirmed by histopathology; and confirmed as MSS/pMMR type by immunohistochemistry or genetic testing;
- •The investigators evaluate that the treatment regimen of cediranib combined with immune checkpoint inhibitors is applicable;
- •Clear consciousness, able to answer questions correctly;
- •Capable of using mobile phones and accessing the internet, with 3G/4G/5G function of smart mobile devices.
排除标准
- •There are serious complications that interfere with the efficacy and safety analysis;
- •The investigators determined that the subjects were not suitable for inclusion in this study.
结局指标
主要结局
Grade 3-4 adverse effects rate
时间窗: From date of randomization until the date of death from any cause, assessed up to 2 years]
Rate of HDACi and immunotherapy and others treatments related severe adverse events
次要结局
- Objective response rate（ORR）(about a year)
- Overall survival (OS)(2 years)
- Progression-free survival（PFS）(2 years)
- Duration of Response（DOR）(2 years)
- Clinical benefit rate （CBR）(2 years)
研究者
研究点 (1)
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