Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence

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

Chemotherapy, PD-1 antibody

标签

MSI-H/ MMRd、MSS/ MMRp

评论

Trial in China, for patients who are having surgery for colorectal cancer liver metastasis.
with/without radiotherapy (SBRT} and immunotherapy
The study will how post-operation chemotherapy (the standard of care) works compared to the combination of radiation, immunotherapy (sintilimab, anti PD-1) and chemotherapy (experimental).

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

Fan Xia, M.D, PH.D
联系方式
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