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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
treatment option-sintilimab plus fruquintinib
Other interventionsintilimab plus fruquintinib
treatment option-fruquintinib alone
Other interventionfruquintinib alone
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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