Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients
Trial Parameters
Brief Summary
The goal of this clinical trial is to learn about efficacy of Vitamin E in combination with Fuquinitinib and Tirelizumab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups.
Eligibility Criteria
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 al