Colorectal cancer
Conditions
Interventions
One month post-surgery, ctDNA was positive.:RectDNA levels after three months of adjuvant chemotherapy.
One month after surgery, ctDNA was negative.:Three months of adjuvant chemotherapy followed by cessation of chemotherapy.
Sponsors
Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: This study was approved by the Ethics Committee of Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine. Patients met the diagnostic criteria for colorectal cancer outlined in the Chinese Guidelines for the Diagnosis and Treatment of Colorectal Cancer (2017 Edition) and received histopathological confirmation of colorectal cancer. 1) Pathological staging was classified as Stage II high-risk (pT4, poorly differentiated [high grade, excluding dMMR/MSI-H], vascular/lymphatic invasion, lymph node dissection <12 nodes, intestinal obstruction or perforation, positive resection margin or insufficient safety margin, or unknown status) or Stage III low-risk (pT1-3N0M0). neural invasion, lymph node dissection <12 nodes, intestinal obstruction or perforation, positive resection margins or insufficient safety margins or unknown status) or low-risk stage III (pT1-3N1M0) according to the 8th edition AJCC colorectal cancer staging criteria; 2) Underwent radical surgical resection; 3) Possessed complete ctDNA methylation testing and TCM intelligent pattern identification data; 4) Age 18–80 years; 5) Expected survival =6 months; 6) ECOG performance status <1/2 or PS =2; Complete blood count, liver, and kidney function meet chemotherapy criteria; No severe dysfunction of major organs (e.g., heart, lungs, brain); Informed consent obtained from participants and families, with voluntary signing of informed consent forms and willingness to complete full-term follow-up.
Exclusion criteria
Exclusion criteria: 1) Age 80 years; 2) Patients with concurrent primary malignancies; 3) Patients with autoimmune diseases, hematologic disorders, or severe organic diseases; 4) Patients unable to tolerate chemotherapy due to conditions such as severe gastrointestinal disease or bone marrow failure; 5) Severe hepatic or renal insufficiency; 6) Pregnant or lactating women; 7) Patients with psychiatric disorders who are non-compliant with study protocols; 8) Patients who have received other relevant treatments that may affect study outcome measures, or who are currently participating in other clinical trials; 9) Patients with distant tumor metastases or peritoneal seeding, or those with residual tumor following surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival rate;Progression-free survival;Methylation of circulating tumor DNA;Traditional Chinese Medicine Syndrome Classification;Facial, Tongue, and Pulse Data Analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactXuan Liu
Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed