Stage II high-risk, stage III low-risk resectable colon cancer
Conditions
Interventions
MRD- deferred adjuvant therapy:In MRD- deferred adjuvant therapy group, patients won’t get the standard CAPEOX adjuvant therapy at first. When MRD negative status turns to positive status, the 3-month
MRD- standard adjuvant therapy:In MRD- standard therapy groups, patients will receive 3-month CAPEOX therapy.
MRD+ standard adjuvant therapy:In MRD+ standard therapy groups, patients will receive 3-month CAPEOX therapy.
MRD+ intensive adjuvant therapy:In the MRD+ intensive standard therapy group, which represents a high risk of recurrence, patients will receive 3-month mFOLFOXIRI intensive therapy.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: Over 18 years old (including 18 years old) and under 70 years old (including 70 years old) when signing the informed consent form 2: The Eastern Cooperative Oncology Group (ECOG) physical status scores are 0-1 and do not deteriorate within 2 weeks before enrollment. The expected survival time is no less than 12 weeks 3: Histological or cytological confirmed stage II high-risk and stage III low-risk none MSI-H colon adenocarcinoma according to the UICC/AJCC TNM stage (8th edition). High-risk factors for stage II patients include: T4, poorly differentiated histology (high-grade, excluding MSI-H status), vascular invasion, neural invasion, intestinal obstruction or tumor site perforation pre-operation, positive or unknown margins, insufficient margin distance and examined lymph nodes less than 12. Stage III low-risk patients include patients with T1-3N1 (excluding T4 or N2) 4: No evidence of distant metastasis (distant organ and/or distant lymph node metastasis) confirmed by comprehensive examination 5: The distal end of the tumor is =12cm from the anal edge evaluated by pre-operative endoscopy. If the endoscopy is absent before surgery, the distance could be evaluated by radiology or during the surgery 6: Patients who have not received neoadjuvant therapy and can achieve R0 radical resection 7: Sufficient surgical fresh tissue samples for customized personalized MRD testing panels detected by WES; available for preoperative blood, post-operative day (POD) 3-7 blood, and POD 21-30 blood samples for MRD testing. 8: Females of the childbearing period should take appropriate contraceptive measures and should not breastfeed from the screening stage to 3 months post-treatment. Before starting treatment, a negative pregnancy test, or one of the following criteria should be confirmed for no risk of pregnancy:a. Post-menopause, defined as age greater than 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy. b. Women younger than 50 years who have been amenorrhea for 12 months or more after cessation of all exogenous hormone therapy and whose luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within laboratory postmenopausal reference values can also be considered as post-menopausal. c. Have undergone irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, except bilateral tubal ligation. 9: Male participants should use barrier contraception (i.e., condoms) from the screening stage to 3 months post-treatment 10: The participants volunteer to join in the study and signed the informed consent in writing 11: Patients who are suitable for CAPEOX and mFOLFOXIRI adjuvant therapy.
Exclusion criteria
Exclusion criteria: 1. Received any of the following treatments: a. Received neoadjuvant therapy in the past; b. Previously received any systemic chemotherapy or immunotherapy for colon cancer; c. Previously received any radiotherapy for colon cancer; d. Undergone colon cancer surgery in the past; 2. Previously or concomitantly diagnosed of other malignant tumors (except for adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer); 3. Patients with other histological types rather than adenocarcinoma (such as neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.); 4. MSI-H/dMMR patients; 5. Pathological, clinical, or radiologic evidence of metastatic lesions, including isolated, distant, or discontinuous intra-abdominal metastases; 6. Patients with multiple primary colorectal cancer; 7. Received other parts of open surgery rather than the colon within 14 days prior to the patient's enrollment; 8. Cannot provide surgical tissues for customized personalized MRD testing or fail to customize personalized MRD testing panels. 9. Cannot provide pre-operative blood, POD 3-7 blood, and POD 21-30 for MRD testing. 10. Suffer from other serious diseases that may affect the follow-up and short-term survival according to the judgment of the investigators; 11. Any other medical conditions and social/psychological problems, which make the patient unfit to participate in this study; 12. History of blood transfusion within 2 weeks before surgery or during surgery; 13. Those who cannot afford contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT) for clinical follow-up; 14. Previously used Chinese patent medicine (CPM) with anti-tumor effect. Those who have used CPM with anti-tumor effect for less than 7 days, and have stopped for over 2 weeks can be enrolled in the study; 15. Have serious or uncontrolled systemic diseases (such as severe mental disease, neurological disease, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal diseases, left ventricular ejection fraction (LVEF) < 50%, evidence of uncontrolled hypertension [greater than or equal to CTCAE grade 3 hypertension despite drug therapy]); patients with dysphagia, active gastrointestinal disease, or other diseases that significantly affect drug absorption, distribution, metabolism, and excretion. Those who have ever undergone major gastrectomy; 16. Fever and body temperature above 38°C within the past 1 week, or active infection with clinical significance. Active tuberculosis. Active fungal, bacterial, and/or viral infections requiring systemic treatment; 17. Those with active bleeding or new thrombotic disease who are taking therapeutic anticoagulant drugs or have bleeding tendency; 18. Those with severe clinical abnormalities in rhythm, conduction, or morphology on the resting electrocardiogram, such as complete left bundle branch block, second-degree cardiac block, clinically significant ventricular arrhythmia, or atrial fibrillation, unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class = 2; 19. Myocardial infarction, coronary/peripheral artery bypass, or cerebrovascular accident occurred within 3 months; 20. QT interval (QTc) =450ms for males and =470ms for females in 12-lead electrocardiogram; 21. Presence of risk factors leading to prolongation of the QTc or arrhythmia, such as heart failure, =CTCAE (version 4.03) 2nd-degree hy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) time in MRD- groups;OS time in MRD+ groups;RFS time in MRD+ groups;Relapse-free survival (RFS) time in MRD- groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory outcomes; | — |
Countries
China
Contacts
Public ContactGong Chen
Sun Yat-sen University Cancer Center
Outcome results
None listed