MRD-positive Colorectal Cancer Patients Combined With Personalized Immune Regulation Diagnosis

Inclusion criteria

• They must give informed consent, indicating that they understand the purpose of the study and the procedures required, and are willing to participate in the study.
• Age 18-80.
• Pathological examination confirmed colorectal adenocarcinoma.
• For patients with stage II with high risk factors or stage III with radical surgery, stage II (high risk) colon cancer is defined as (any of):

a )T4 b)≥ Level 3 c) The clinical manifestations are intestinal obstruction or intestinal perforation d) Histological signs of vascular, lymphatic, or perineural invasion e) Check < 12 nodes

• Patients with liver or lung metastases that can be resected in one stage with the primary lesion.
• There must be sufficient formalin to fix the tumor material in the paraffin embedded (FFPE) block or section tissue (only after sponsor approval), preferably obtained from excision.
• Patients should meet the following biochemical indicators: total bilirubin ≤2× upper limit of normal (ULN); AST and ALT≤2× upper limit of normal (ULN); Creatinine clearance ≥60 ml/min.
• Patients should meet the following hematological indicators: neutrophil count ≥1.5×109 /L; Hemoglobin ≥10.0 g/dL; Platelet count ≥100×109 /L.
• Expected survival ≥ 3 months.
• Postoperative ctDNA MRD test was positive, routine blood indexes were negative, and imaging was negative.

Exclusion criteria

• Stage I patients and stage II patients without risk factors or MSI-H.
• Stage IV patients who cannot be surgically resected.
• Patients with liver, kidney, heart, lung and other dysfunction, unable to tolerate surgery or unable to complete follow-up chemotherapy.
• Patients who refuse adjuvant therapy such as chemotherapy, are allergic to chemotherapy drugs and have poor compliance.
• Patients who have received other immunotherapy within 1 month (such as immune checkpoint inhibitor therapy, therapeutic antibody therapy, immune cell therapy, and immune system modulator therapy)
• Patients with a known past or current malignancy, except where a diagnosis is included, except in the following cases:

• Stage 1B or below cervical cancer.
• Non-invasive basal cell or squamous cell skin cancer.
• Non-invasive superficial bladder cancer.
• Prostate cancer with a current PSA level < 0.1 ng/mL.
• Any curable cancer with a complete response (CR) duration of > 2 years.
• Patients with hematological and autoimmune diseases.
• Patients with active hepatitis B or C.
• Patients affected by drug abuse, clinical or psychological or social factors that make informed consent or the implementation of research.
• Pregnant and lactating women.
• Patients with mental illness, senile dementia, etc.