The Study on the Efficacy and Safety of Lactobacillus Johnsonii in Combination with CapeOX and Pembrolizumab for the Treatment of MSS/pMMR Metastatic Colorectal Cancer.

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Feb 9, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for people with metastatic colorectal cancer (CRC) who have already tried standard chemotherapy treatments without success. Researchers want to see if adding a specific probiotic called Lactobacillus johnsonii to a combination of chemotherapy (CapeOX) and an immunotherapy drug (Pembrolizumab) can be both effective and safe for these patients. The trial will compare two groups: one receiving the standard treatment along with a placebo, and the other receiving the same treatment but with Lactobacillus johnsonii.

To participate in this study, you need to be between 18 and 75 years old and have a confirmed diagnosis of MSS or pMMR colorectal cancer that has spread and cannot be surgically removed. You should have already tried standard treatments and your cancer must be confirmed through specific tests. It’s important to note that people with certain medical conditions, recent antibiotic use, or ongoing infections won't be eligible. If you qualify and decide to join, you’ll be randomly assigned to one of the treatment groups and will attend regular study visits to monitor your health and the effects of the treatment. This trial is not yet recruiting participants, but it aims to offer new hope for patients struggling with advanced colorectal cancer.

Gender

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Eligibility criteria

• • Inclusion Criteria
• • Ages between 18 and 75 years old;
• • Pathologically confirmed MSS or pMMR colorectal adenocarcinoma (PCR method, with 0 or 1 locus unstable; or immunohistochemical method, with expression of MLH1/MSH2/MSH6/PMS2 proteins);
• • Patients who have failed standard first- and second-line treatments (including CapeOX ± targeted therapy, FOLFOX ± targeted therapy, 5-FU/LV ± targeted therapy); ④ Radiological imaging indicates distant metastases throughout the body, considered as unresectable lesions; ⑤ Willingness to comply with the study visit schedule, as well as the prohibitions and restrictions stipulated in this agreement.
• • Exclusion Criteria
• • Use of antibiotics within 4 weeks prior to treatment;
• • Concurrent immunodeficiency diseases (such as HIV or post-transplantation status) or receipt of high-dose systemic corticosteroid therapy or any other form of immunosuppressive therapy within the last 4 weeks;
• • Concurrent malignancies in other organs; ④ Concurrent active autoimmune diseases (i.e., requiring corticosteroids or immunosuppressant medications);
• • Concurrent active infections requiring systemic treatment; ⑥ Concurrent severe systemic diseases, diseases of vital organs such as the heart, lungs, and brain, liver and renal insufficiency, among others;
• • Participation in other drug studies within 3 months prior to treatment or inability of the patient to correctly express their chief complaints and cooperate with this study; ⑧ Any severe or uncontrolled medical condition that, in the investigator's opinion, may increase the risks associated with study participation or study drug administration, impair the subject's ability to receive the protocol-specified treatment, or interfere with the interpretation of study results.