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ACTIVE NOT RECRUITING
NCT06865521
NA

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

Sponsor: West China Hospital

View on ClinicalTrials.gov

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.

Official title: Safety and Feasibility of Akkermansia Probiotics Combined With Anti-PD-1 Monoclonal Antibody in MSS/pMMR Advanced Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2025-02-21

Completion Date

2027-03-21

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

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.

Locations (2)

Colorectal Cancer, West China Hospital

Chengdu, Sichuan, China

Colorectal Cancer, West China Hospital

Chengdu, Sichuan, China