Effect of Gut Microbiota and Its Metabolites on the Efficacy of Immunotherapy in Metastatic Colorectal Cancer

Jilin University

Status

Enrolling

Conditions

Colorectal Neoplasms Malignant

Treatments

Other: treatment option-sintilimab plus fruquintinib

Other: treatment option-fruquintinib alone

Study type

Observational

Funder types

Other

Identifiers

NCT06714903

2024-HS-147

Details and patient eligibility

About

The purpose of this observational study is to understand the effect of gut microbiota on the efficacy of immunotherapy in patients with metastatic colorectal cancer and to explore the specific mechanisms of this process. In this way, it provides new ideas for the clinical treatment of colorectal cancer.

Full description

This study is a single-center, prospective, observational study. This study plans to enroll 50 patients with mCRC who received immunotherapy. Stool and blood samples were collected from patients with mCRC before receiving immunotherapy (baseline) and after one cycle of immunotherapy and stored immediately in a -80°C freezer. Six months after treatment with a PD-1 inhibitor in combination with fruquintinib, patients with mCRC were evaluated radiographically according to the modified RECIST1.1 criteria for immunotherapy (iRECIST) and were divided into responsive and non-responsive groups.

In this study, we intend to use metagenomic sequencing to screen the key intestinal microbiota that affect the efficacy of PD-1 inhibitors and predict their possible functional pathways in patients with metastatic colorectal cancer receiving anti-PD-1 immunotherapy. Then, proteomics and metabolomics methods were used to screen differential proteins and metabolites, and the correlation analysis with key intestinal microbiota was carried out, and the efficacy of immunotherapy in patients with mCRC was evaluated. Finally, the above findings were verified in animal models, and then the specific mechanism of intestinal microbiota affecting the efficacy of PD-1 inhibitors was explained by taking the changes in body metabolism and immunity as the starting point.

Enrollment

50 estimated patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical and pathological diagnosis of metastatic colorectal cancer
35-75 years old (both ends inclusive)
complete clinical information
signed informed consent

Exclusion criteria

combined with severe respiratory and circulatory diseases
combined with other malignant tumors
recent severe active bleeding, uncontrolled active infection or active peptic ulcer
moderate to severe renal insufficiency
other circumstances that are judged by the investigator to be unsuitable for participating in this study