Colorectal Cancer
Conditions
Interventions
Trial group:Oral administration of berberine will be initiated simultaneously with postoperative chemotherapy (the chemotherapy regimen is formulated in accordance with the 2025 CSCO Guidelines for Co
Placebo group:Oral administration of placebo will be initiated concurrently with postoperative chemotherapy (the chemotherapy regimen is formulated in accordance with the 2025 CSCO Guidelines for Colo
Sponsors
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with IIIB and IIIC colorectal cancer as the first treatment after radical surgery based on pathological diagnosis 2. Age range from 18 to 75 years old 3.ECOG score <= 2 4.Patients who start adjuvant chemotherapy within 6 weeks after radical surgery for colorectal cancer 5.According to imaging assessment, there is no local or distant recurrence of the tumor 6.The subjects are able to communicate well with the researchers and complete the study in accordance with the research regulations 7.Patients who voluntarily sign a consent form after fully understanding and comprehending the purpose and procedures of this study, disease characteristics, drug effects, relevant examination methods, and potential risks/benefits of this study.
Exclusion criteria
Exclusion criteria: 1.Suffering from severe heart, liver, or kidney disease 2.Patients with a personal history of other tumors within the past 5 years 3.Patients with mental illness and those who are confused and unable to communicate verbally 4.Patients who are allergic or intolerant to drugs 5.Pregnant women, lactating women, or women who are expected to become pregnant 6.Mentally ill patients who are unable to cooperate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence and metastasis rate within 1 year;Recurrence and metastasis rate within 2 years;Incidence of Adverse Events;Gut microbiota;Metabolomics; | — |
Countries
China
Contacts
Public ContactChen Haitao
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed