Akkermansia Probiotics Plus Anti-PD-1 Monoclonal Antibody in MSS/pMMR Advanced Colorectal Cancer

Other illness

• • History of allergic diseases, severe drug allergies, or known allergies to probiotic drugs
  • Use of antibiotics or probiotic drugs/health products within the last 3 months
  • History of other malignancies with a disease-free interval of less than 5 years (except for cured basal cell carcinoma of the skin, cured cervical carcinoma in situ, and gastrointestinal tumors cured by endoscopic mucosal resection)
  • Presence of any active autoimmune disease or history of autoimmune disease
  • Current use of immunosuppressants or hormone therapy, continued within 2 weeks prior to enrollment
  • Concurrent severe infections
  • Congenital or acquired immune deficiency, or active hepatitis
  • Concurrent severe complications

• • Age 18-75 years
  • ECOG performance status score of 0-2
  • Histopathologically confirmed colorectal cancer; tumor tissue immunohistochemistry or genetic testing showing pMMR or MSS/MSI-L type
  • Metastatic colorectal adenocarcinoma that has failed standard treatments (including irinotecan, oxaliplatin, fluorouracil, bevacizumab, cetuximab, etc.)
  • No prior use of immunotherapy (such as immune checkpoint inhibitors, adoptive cell immunotherapy, etc.)
  • At least one evaluable lesion according to RECIST version 1.1 criteria
  • No intestinal obstruction and good oral compliance
  • Adequate bone marrow, liver, and kidney function to receive treatment
  • Signed informed consent