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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-75
SponsorThe First Hospital of Jilin University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical and pathological diagnosis of metastatic colorectal cancer

35-75 years old (both ends inclusive)

complete clinical information

signed informed consent

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • treatment option-sintilimab plus fruquintinib

    Other intervention

    sintilimab plus fruquintinib

  • treatment option-fruquintinib alone

    Other intervention

    fruquintinib alone

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Experimental group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of efficacy

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. Patients are classified as responders if they achieve an objective response (complete or partial response or stable disease for at least 6 months), while patients are classified as non-responders if they have progressed on treatment or have stable disease for less than 6 months.

Time frame
six months after treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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