Understanding how gut bacteria affect immunotherapy in metastatic colorectal cancer
Multi-omics Study of Intestinal Microecology in Patients with Colorectal Cancer Related to Immunotherapy
This study is trying to see how the bacteria in the gut affect the success of immunotherapy in people with advanced colorectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Drugs / interventions | immunotherapy, fruquintinib |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT06714903 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the impact of gut microbiota on the effectiveness of immunotherapy in patients with metastatic colorectal cancer (mCRC). It will enroll 50 patients who have received immunotherapy, collecting stool and blood samples before and after treatment. The study will utilize metagenomic sequencing to identify key intestinal microbiota and their functional pathways, alongside proteomics and metabolomics to analyze differential proteins and metabolites. The findings will be validated in animal models to elucidate the mechanisms by which gut microbiota influence immunotherapy efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35-75 with a clinical and pathological diagnosis of metastatic colorectal cancer who can provide complete clinical information.
Not a fit: Patients with severe respiratory or circulatory diseases, other malignant tumors, or significant renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized immunotherapy approaches for patients with metastatic colorectal cancer based on their gut microbiota composition.
How similar studies have performed: While the role of gut microbiota in cancer treatment is an emerging field, this specific approach to studying its impact on immunotherapy in mCRC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Changchun, Jilin
- The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
Study contacts
- Study coordinator: Nan Zhang
- Email: zhangnan@jlu.edu.cn
- Phone: 18686440802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.