Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients

Inclusion Criteria

• •1. Age ≥18 years old, both sexes;
• •2. Patients with histologically or cytologically confirmed unresectable and metastatic CRC;
• •3. Recist1.1-defined disease progression or intolerance to prior standard therapy during or after standard therapy. Standard therapy was required to include all the following agents: fluorouracilines, chemotherapy agents such as irinotecan, and oxaliplatin, with or without an anti-VEGF monoclonal antibody (e.g., bevacizumab). Left-sided KRAS/NRAS/BRAF wild-type subjects received combined anti-EGFR mAb (cetuximab or panitumumab).
• •4. Before enrollment, the tumor tissue was pMMR by immunohistochemistry, or MSS or MSI-L by PCR or NGS;
• •5. Patients with ECOG score of 0-1 and expected survival time ≥3 months, patients who can cooperate to observe adverse reactions and efficacy;
• •6. At least one measurable tumor lesion according to RECIST 1.1 criteria;
• •7. Good organ function:
• •1. neutrophil ≥1.5\*109/L; Platelet ≥100\*109/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl;
• •2. Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal, T3 and T4 in the normal range;
• •3. bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤ 2 times the upper limit of normal;
• •4. Serum creatinine ≤ 1.5 times the upper limit of normal, creatinine clearance ≥60ml/min;
• •5. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of the normal range, unless the patient is receiving anticoagulant therapy and the PT value is within the intended range for anticoagulant therapy;
• •6. Activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal;
• •8. There were no serious concomitant diseases that could make the survival time less than 5 years;
• •9. Negative pregnancy test in female subjects (for female patients of childbearing potential); Infertile female patients;
• •10. Male patients of childbearing potential and female patients of childbearing potential and at risk of pregnancy must agree to use adequate contraception for the entire duration of the study and for 12 months after receiving treatment with the protocol;
• •11. Signed and dated informed consent indicating that the patient has been informed about all relevant aspects of the study;
• •12. Patients who are willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other study procedures;
• •13. Willing to comply with the arrangement during the study period can not participate in any other clinical research on drugs and medical devices.