Locally advanced colorectal cancer
Conditions
Interventions
Medium-dose group:Oral medication
High-dose group:Oral medication
low-dose group:Oral medication
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years old; 2) Confirmed diagnosis of locally advanced colorectal cancer (colorectal cancer stage cT3-4, N0 or any cT, N+) by histopathology of tissue/cells, and determined by the investigator to be resectable after neoadjuvant chemotherapy for the first time; 3) Has not received systemic treatment (including any chemotherapy, targeted therapy or immunotherapy); 4) Has not received local or systemic antibiotic treatment within 3 months; 5) ECOG-PS score 0-2, with an expected survival of more than 12 months; 6) Hematological, biochemical and organ function indicators meet the requirements for clinical chemotherapy treatment, without severe comorbidities or other contraindications for treatment, and is eligible for chemotherapy drugs; 7) No clinical evidence of other malignancies, unstable complications or uncontrolled infections.
Exclusion criteria
Exclusion criteria: 1) Women who are pregnant or lactating, or who have plans to become pregnant during anti-tumor treatment; 2) Those with other malignant diseases requiring systemic treatment, severe autoimmune diseases, or other contraindications to treatment; 3) Those with uncontrolled infections currently, with a body temperature of = 38?; 4) Those with severe heart, lung, kidney, liver, vascular diseases, mental disorders, or drug abuse; 5) Those with an ECOG score of 3 or above; 6) Those currently participating in other clinical trials; 7) Those taking oral anticoagulants such as warfarin; 8) Those with MSI-H/dMMR; 9) Those not listed in the exclusion criteria but considered unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the intestinal and intratumoral microbiota; | — |
Countries
China
Contacts
Public ContactMa Jie
Beijing Hospital
Outcome results
None listed