计划状态
招聘阶段
第二阶段允许先接受免疫治疗
是CRC 指导的试验
是药物
化疗、PD-1 抗体标签
MSI-H/ MMRd、MSS/ MMRp评论
在中国进行的针对结直肠癌肝转移手术患者的试验。
联合/不联合放疗(SBRT)和免疫疗法
该研究将探讨手术后化疗(标准疗法)与放疗、免疫疗法(sintilimab,抗 PD-1)和化疗(试验性疗法)联合治疗的效果对比。
地点 | 位置状态 |
---|---|
中国 | |
复旦大学上海肿瘤防治中心 上海,上海 200032 |
招聘 |
联系方式
纳入标准
纳入标准
age ≥ 18 years old, female and male
pathological and imaging confirmed colorectal colorectal liver metastases (synchronous or heterochronous)
Metastatic liver lesions <= 5
Primary colorectal cancer under control
Absence of evidence of extra-hepatic diseases
Metastatic liver lesions received resection with insufficient margin (= 70
Adequate organ function without contraindications to surgery, radiotherapy and immunotherapy
Without previous antitumoral immunotherapy
With good compliance
Signed the inform consent
排除标准
排除标准:
Pregnancy or breast-feeding women
History of other malignancies within 5 years (except cured skin cancer and cervical cancer in situ)
History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders
Clinically serious heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
Immunodeficiency disease, autoimmune diseases or long-term using of immunosuppressive agents
Severe uncontrolled recurrent infections
Baseline blood and biochemical indicator do not meet the following criteria: neutrophils >=1.5×10^9/L, Hb >=90g/L, PLT >=100×10^9/L, ALT/AST<=2.5 ULN, Cr <= 1ULN
Allergic to any component of the therapy