advanced colorectal cancer
Conditions
Interventions
experimental group:Fecal bacteria transplantation + immunotherapy
control group:Immunotherapy only
Sponsors
Xijing Hospital of the Fourth Military Medical University of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects aged between 18 to 75 years old; 2.Biopsy pathology confirmed colorectal adenocarcinoma; 3.CT/MR/PET-CT suggested distant metastasis; 4.The tumor was assessed by MDT as an advanced, initially unresectable state; 5.Immunohistochemistry and gene analysis indicated MSH-H/dMMR; 6.Life expectancy is more than 3 months; 7.ECOG confirmed clinical status of 0-2; 8.sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Tumors other than colorectal adenocarcinoma, or rectal malignant tumors on the basis of inflammatory bowel disease; 2. Clinically diagnosed active heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or myocardial infarction within the last 12 months history of infarction; 3. Contraindications to chemotherapy and immunotherapy, including serious infections, drug interactions; 4. Pregnant and lactating women; 5. The investigator judges that the compliance is poor or not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| The bacterial spectrum;Changes in immune microenvironment;Changes in minimal residual disease ; | — |
Countries
China
Contacts
Public ContactZheng Jianyong
Xijing Hospital of the Fourth Military Medical University of the Chinese People's Liberation Army
Outcome results
None listed