A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decisions in Postoperative Stage I or Low-Risk Stage II Colorectal Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Patient's 2-year Progression-Free Survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Receipt of neoadjuvant therapy prior to surgery;
- •Blood transfusion during surgery or within 2 weeks prior to surgery;
- •Pregnant or breastfeeding women, or individuals of reproductive potential who are not using adequate contraception;
- •History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer;
- •Uncontrolled primary brain tumors or central nervous system metastases, or presence of significant intracranial hypertension or neuropsychiatric symptoms;
- •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; Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
研究组 & 干预措施
Follow-up Group
In the follow-up group, patients with stage I and low-risk stage II CRC will not receive adjuvant therapy after surgery and will undergo ctDNA assessments at 3 and 6 months postoperatively.
Single-agent chemotherapy group
Patients with stage I colorectal cancer (CRC) will receive capecitabine monotherapy for 6 months. For patients with stage II CRC, adjuvant treatment will consist of either capecitabine monotherapy for 6 months or FOLFOX/CAPOX for an initial 3 months. After 3 months of treatment, ctDNA status will be reassessed: patients who convert to ctDNA-negative will continue capecitabine monotherapy for an additional 3 months, whereas those who remain ctDNA-positive will switch to FOLFIRI/CAPEIRI for a further 3 months. In addition, venous blood samples (8-16 mL) will be collected at 3 and 6 months postoperatively for dynamic monitoring of plasma ctDNA.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Patient's 2-year Progression-Free Survival
时间窗: Two-year Progression-Free Survival
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.
次要结局
- ctDNA-clearance Rate(3 month and 6 month after surgery)
研究者
Guoxiang Cai
Fudan University Shanghai Cancer Center
Fudan University