Actively Recruiting
Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in High-Risk Stage III Colorectal Cancer T4N or T1-3N2
Led by Fudan University · Updated on 2026-05-01
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates adjuvant chemotherapy decision-making for patients with high-risk stage III colorectal cancer, specifically those with T4N or T1-3N2 disease. It evaluates the use of plasma circulating tumor DNA ctDNA methylation to guide treatment choices. The study is a randomized controlled trial sponsored by Fudan University, focusing on how adding bevacizumab to standard chemotherapy affects patient outcomes. Participants will be randomly assigned to one of two groups the control group will receive standard chemotherapy with FOLFOX or CAPOX for six months, while the intervention group will receive the same chemotherapy combined with bevacizumab for six months. Blood samples will be collected at one, three, and six months after surgery to monitor plasma ctDNA dynamically. During the study, participants will undergo regular assessments including blood draws for ctDNA analysis. Researchers will measure outcomes such as the patients two-year progression-free survival and ctDNA clearance rate at six months. The study aims to follow participants over a two-year period to evaluate treatment effects and safety.
CONDITIONS
Brief Title
A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decision-Making in High-Risk Stage III (T4N+ or T1-3N2) Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any sex
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with expected survival greater than 3 months
- Histologically confirmed postoperative high-risk stage II colorectal cancer
- Positive ctDNA status one month after surgery
- Expected survival greater than 12 months
- Ability to understand and sign informed consent personally or via authorized representative
You will not qualify if you...
- Receipt of neoadjuvant therapy before surgery
- Blood transfusion during surgery or within 2 weeks prior
- Pregnant or breastfeeding women, or those not using adequate contraception if of reproductive potential
- History of other malignancies within 5 years except treated carcinoma in situ of cervix or non-melanoma skin cancer
- Uncontrolled brain tumors, central nervous system metastases, intracranial hypertension, or neuropsychiatric symptoms
- Severe or uncontrolled comorbidities including unstable cardiac disease, neurological or psychiatric disorders, severe infections, active disseminated intravascular coagulation, significant bleeding tendency, or major organ impairment
- Any other condition making participation unsuitable per investigator judgment
Research Team
G
Guoxiang Cai
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here