Colorectal cancer
Conditions
Interventions
Extended treatment group:CAPEOX treatment for 6 months
Observation group:CAPEOX treatment for 3 months
Sponsors
Northern Jiangsu People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The diagnosis of colorectal cancer was confirmed by pathological histology examination; 2. The pathological stage was stage II high-risk (pT4, poor differentiation (high grade, excluding dMMR/MSI-H), vascular/neural invasion, insufficient lymph node dissection (less than 12), intestinal obstruction or perforation, positive resection margin or insufficient safe distance or unknown conditions) or stage III low-risk (pT1-3N1M0), according to the 8th edition of the AJCC staging criteria for colorectal cancer; 3. Radical surgical resection was performed; 4. ctDNA methylation remained positive (positive at 1 month after surgery and remained positive after 3 months of CAPEOX chemotherapy); 5. PS score = 3 years; 6. No preoperative neoadjuvant chemotherapy or radiotherapy was received; 7. Liver and kidney functions, blood routine met the chemotherapy standards: neutrophils >= 1.5 × 10?/L, platelets >= 100 × 10?/L, hemoglobin >= 90 g/L; alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 60 ml/min (calculated using the Cockcroft-Gault formula); 8. No severe functional disorders of important organs such as heart, lungs, and brain; 9. The subjects and their families gave informed consent, voluntarily signed the informed consent form, and could cooperate to complete the entire follow-up.
Exclusion criteria
Exclusion criteria: 1. Combine with other malignant tumors (except for pre-disposed tumors such as skin basal cell carcinoma and cervical carcinoma in situ with favorable prognosis); 2. Have conditions that cannot tolerate chemotherapy, such as severe gastrointestinal diseases, bone marrow failure, etc.; 3. Allergic to capecitabine or oxaliplatin in the CAPOX regimen; 4. Have mental disorders or cognitive impairments, and are unable to understand the research content and cooperate with follow-up; 5. Pregnant or lactating women; 6. Currently participating in other clinical studies that may affect the results of this research; 7. Have distant metastasis of tumors or peritoneal implantation metastasis; 8. Have tumor remnants after surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3y-DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-Year Disease-Free Survival Rate;ctDNA Clearance Rate;Incidence of Grade >= 3 Adverse Reactions;Quality of Life Score (QoL Score); | — |
Countries
China
Contacts
Public ContactDai Erxun
Northern Jiangsu People's Hospital
Outcome results
None listed