Akkermansia Probiotics: After enrollment, patients will receive anti-PD-1 monoclonal antibody + Tyrosine kinase inhibitor (TKI, e.g., regorafenib, fruquintinib) treatment or anti-PD-1 monoclonal antibody ± chemotherapy (etc., CAPEOX \[oxaliplatin+capecitabine \], XELIRI \[irinotecan+capecitabine \]) ± Bevacizumab treatment (anti-PD-1 monoclonal antibody, chemotherapy, and bevacizumab every 3 weeks, TKI every 4 weeks), along with daily continuous administration of Akkermansia probiotics (Songke, dose: 1 capsule/day, taken with breakfast), until disease progression, intolerable toxicity, or patient withdrawal from the study.
Study summary
The investigators propose to conduct a single-center, single-arm, Phase I clinical study to explore the safety and feasibility of Akkermansia probiotics combined with anti-PD-1 monoclonal antibody in patients with MSS/pMMR advanced colorectal cancer, as well as its impact on gut microbiota and the immune microenvironment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* • 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
Exclusion Criteria:
* • 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
Primary outcome measure(s)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 — From enrollment to one months after study exit Physical Symptoms (Nausea, vomiting, headache, dizziness, fatigue, rash, itching, pain, etc); Laboratory Abnormalities: (Abnormal blood test results); Clinical Signs (ever, swelling, high blood pressure, low blood pressure, rapid heart rate, etc); Worsening of Pre-existing Conditions (xacerbation of a pre-existing disease or medical condition); New Medical Conditions (Development of new diseases or disorders that were not present before treatment); Psychological Effects (Anxiety, depression, insomnia, confusion, etc).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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