Advanced refractory colorectal cancer
Conditions
Interventions
Experimental group:PD-1 inhibitor + colon-targeted FMT
Control group:PD-1 inhibitor + enterobacteria-free colon targeting preparation
Sponsors
The Second Affiliated Hospital of Nanjing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed colorectal cancer, subjects with evidence of stage IV metastatic disease, who cannot be resected at one stage; 2. Voluntarily participate and sign informed consent; 3. Over 18 years old, male or female; 4. More than second-line treatment is required, subjects have previously received mCRC first-line and second-line standard treatment according to NCCN or CSCO guidelines, and disease progression after treatment; 5. The tumor tissue was indicated as pMMR or MSS type by immunohistochemistry or genetic testing; 6. Standard physical condition (ECOG) score 0-1, life expectancy is more than 3 months; 7. There is at least one measurable lesion that meets the definition of RECIST standard 1.1; 8. Able to swallow drugs, able to follow study protocols and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. The subjects have autoimmune diseases or immune deficiencies and are treated with immunosuppressive drugs. 2. Pregnant and lactating women. 3. According to the judgment of the researcher, other diseases that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment, are likely to cause loss of follow-up. 4. Patients who are participating in clinical trials of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;Duration of stable disease;Duration of overall response;TTP;16s DNA ;OS;Tumor index; | — |
Countries
China
Contacts
Public ContactHeiying Jin
The Second Affiliated Hospital of Nanjing University of Chinese Medicine
Outcome results
None listed