Clinical trial NCT06714903: Effect of Gut Microbiota and Its Metabolites on the Efficacy of Immunotherapy in Metastatic Colorectal Cancer
Official title: Multi-omics Study of Intestinal Microecology in Patients with Colorectal Cancer Related to Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Neoplasms Malignant
Keywords: Metastatic colorectal cancer
Immunotherapy
Gut microbiota
Prognosis
Metabolism
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 50 patients with metastatic colorectal cancer who received immunotherapy from the First Hospital of Jilin University from 2024 to 2026 were included

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of efficacy
timeFrame: six months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Nan Zhang
role: STUDY_DIRECTOR
References: