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

NCT ID: NCT06714903

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Colorectal Neoplasms Malignant

Keywords

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Metastatic colorectal cancer Immunotherapy Gut microbiota Prognosis Metabolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group

sintilimab + fruquintinib

treatment option-sintilimab plus fruquintinib

Intervention Type OTHER

sintilimab plus fruquintinib

Control group

fruquintinib

treatment option-fruquintinib alone

Intervention Type OTHER

fruquintinib alone

Interventions

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treatment option-sintilimab plus fruquintinib

sintilimab plus fruquintinib

Intervention Type OTHER

treatment option-fruquintinib alone

fruquintinib alone

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nan Zhang

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Locations

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The First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nan Zhang

Role: CONTACT

Phone: 18686440802

Email: [email protected]

Facility Contacts

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Nan Zhang

Role: primary

Other Identifiers

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2024-HS-147

Identifier Type: -

Identifier Source: org_study_id