Effect of Gut Microbiota and Its Metabolites on the Efficacy of Immunotherapy in Metastatic Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: treatment option-sintilimab plus fruquintinib, treatment option-fruquintinib alone.
- Who it may be relevant to
- Registry conditions: Colorectal Neoplasms Malignant. Basic parameters: 35 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-omics Study of Intestinal Microecology in Patients with Colorectal Cancer Related to Immunotherapy
Overview
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.
Interventions
- Other treatment option-sintilimab plus fruquintinib
sintilimab plus fruquintinib - Other treatment option-fruquintinib alone
fruquintinib alone
Primary outcome measures
- Evaluation of efficacy [Time frame: six months after treatment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Hospital of Jilin University — Changchun
Identifiers
NCT: NCT06714903 · 2024-HS-147