Clinical trial · Observational
Effect of Gut Microbiota and Its Metabolites on the Efficacy of Immunotherapy in Metastatic Colorectal Cancer
Multi-omics Study of Intestinal Microecology in Patients with Colorectal Cancer Related to Immunotherapy
NCT06714903CI-TRIAL-00083323unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms Malignant | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| treatment option-fruquintinib alone | Other | — | UNRESOLVED |
| treatment option-sintilimab plus fruquintinib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Experimental group
- description
- sintilimab + fruquintinib
- interventionNames
- Other: treatment option-sintilimab plus fruquintinib
- label
- Control group
- description
- fruquintinib
- interventionNames
- Other: treatment option-fruquintinib alone
Primary outcomes (1)
- measure
- Evaluation of efficacy
- timeFrame
- six months after treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.