ctDNA, Colorectal Cancer, Chemotherapy
Conditions
Brief summary
The patient (T4N0 or low-risk stage III) will be randomly assigned to either the control group (FOLFOX/CAPOX for 3 months) or the intervention group (FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months after surgery for dynamic monitoring of plasma ctDNA.
Detailed description
The patient (T4N0 or low-risk stage III) will be randomly assigned to either the control group (FOLFOX/CAPOX for 3 months) or the intervention group (FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months after surgery for dynamic monitoring of plasma ctDNA.
Interventions
DRUGCAPEOX regimen
CAPEOX regimen for 3 months
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years, regardless of sex; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of \>3 months; 3. Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer; 4. Positive ctDNA status at 1 month after surgery; 5. Expected survival of \>12 months; 6. Ability to understand and willingness to sign a written informed consent form (personally or via a legally authorized representative/guardian), indicating that the subject understands the study objectives and required procedures and agrees to participate.
Exclusion criteria
1. Receipt of neoadjuvant therapy prior to surgery; 2. Blood transfusion during surgery or within 2 weeks prior to surgery; 3. Pregnant or breastfeeding women, or individuals of reproductive potential who are not using adequate contraception; 4. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer; 5. Uncontrolled primary brain tumors or central nervous system metastases, or presence of significant intracranial hypertension or neuropsychiatric symptoms; 6. Presence of severe or uncontrolled comorbidities, including but not limited to:Severe cardiac disease that remains unstable despite treatment, including myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment; Clearly diagnosed neurological or psychiatric disorders, including dementia or seizure disorders;Severe or uncontrolled infections;Active disseminated intravascular coagulation (DIC) or significant bleeding tendency;Significant impairment of major organ function; 7. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's 2-year Progression-Free Survival | 2 years | Two-year Progression-Free Survival (PFS) is defined as the proportion of patients who remain alive without evidence of disease progression or recurrence within 24 months from the date of surgery (or randomization, as specified in the protocol). Disease progression is determined according to radiologic, clinical, or pathological criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ctDNA-clearance Rate | 6 months | ctDNA clearance rate is defined as the proportion of patients with detectable circulating tumor DNA (ctDNA) at baseline who achieve conversion to undetectable ctDNA at a predefined post-treatment time point, as assessed by the specified ctDNA assay. |
Countries
China
Contacts
CONTACTGuoxiang Cai
Outcome results
None listed