局部复发风险高的结直肠肝转移瘤术后化疗加/不加放疗和免疫疗法

计划状态

招聘

阶段

第二阶段

允许先接受免疫治疗

CRC 指导的试验

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

范霞,医学博士,哲学博士
联系人
13564676623 tcxiafan@hotmail.com

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

NCT ID

NCT06120127

添加审判日期

2023-11-07

更新日期

2023-11-07