A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decisions in Postoperative Stage I or Low-Risk Stage II Colorectal Cancer Patients
This study will utilize ctDNA methylation detection to evaluate patients with stage I or low-risk stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. By using postoperative ctDNA status to identify patients at high risk of recurrence, the study seeks to implement intensified chemotherapy strategies (treatment escalation) at an early stage, thereby improving ctDNA clearance and ultimately enhancing patient outcomes.
⁃ Participants must meet all of the following criteria:
• Age ≥18 years, regardless of sex;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of \>3 months;
• Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer;
• Positive ctDNA status at 1 month after surgery;
• Expected survival of \>12 months;
• 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.