Akkermansia Probiotics Plus Anti-PD-1 Monoclonal Antibody in MSS/pMMR Advanced Colorectal Cancer (NCT06865521) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Akkermansia Probiotics Plus Anti-PD-1 Monoclonal Antibody in MSS/pMMR Advanced Colorectal Cancer
China22 participantsStarted 2025-02-21
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timeframe: From enrollment to one months after study exit