Clinical trial · Interventional
Akkermansia Probiotics Plus Anti-PD-1 Monoclonal Antibody in MSS/pMMR Advanced Colorectal Cancer
Safety and Feasibility of Akkermansia Probiotics Combined With Anti-PD-1 Monoclonal Antibody in MSS/pMMR Advanced Colorectal Cancer
NCT06865521CI-TRIAL-00107906active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Akkermansia Muciniphila | — | UNRESOLVED | — |
| Colo-rectal Cancer | Colon Neoplasm | PROBABILISTIC | 0.70 |
| PD-1 Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Akkermansia Probiotics | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Self control group
- description
- According to the inclusion and exclusion criteria, 22 patients will be recruited. 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.
- interventionNames
- Dietary Supplement: Akkermansia Probiotics
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- From enrollment to one months after study exit
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.