Circulating Tumor DNA Guided Therapeutic Strategies for Colorectal Cancer Patients With Small Pulmonary Nodules Suspected to be Metastases: an Open-Label, Prospective, Phase II Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) in advanced colorectal cancer patients with metastatic small pulmonary nodules under ctDNA guided therapeutic strategies
研究概览
简要总结
The clinical diagnosis and treatment of small pulmonary nodules (suspected to be lung metastases) in advanced colorectal cancer patients remain controversy. Previous studies have shown that tumor-informed circulating tumor DNA (ctDNA) blood testing can sensitively detect residual cancer. Postoperative ctDNA in colorectal cancer patients is a valuable biomarker to identify minimal residual disease (MRD) after radical resection, which is possibly useful in redefining the risk group of patients and guiding postoperative treatment. This study aimed to explore the clinical value of therapeutic strategies based on tumor-informed ctDNA test in advanved colorectal cancer patients with small pulmonary nodules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 and ≤80 years old, regardless of gender;
- •Pathologically confirmed as adenocarcinoma of advanced colorectal cancer;
- •Lung lesions only, which was considered as metastatic by imaging consultation, and clinically diagnosed as lung metastasis of colorectal cancer;
- •Multiple lung lesions are allowed, but the maximum lesion diameter should be less than or equal to 2 cm;
- •For lesions larger than 1 cm, local treatment is planned, such as radical surgical resection or local radiotherapy, radio frequency ablation or interventional therapy (absolute alcohol treatment or cryotherapy);
- •Eastern Cooperative Oncology Group (ECOG) score 1 ~ 2;
- •The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study;
- •Surgical specimens or puncture specimens containing tumor tissue are available;
- •20 mL of peripheral blood are available (10 mL per tube, two tubes in total);
- •Agreed to follow up for at least 2 years.
排除标准
- •The pathology was not confirmed by enteroscopic biopsy or biopsy of metastatic lesions;
- •Patients with stage I-III colorectal cancer;
- •Primary lung cancer, GGO, tuberculosis and other non metastatic conditions were excluded after diagnosis by imaging consultation;
- •Presence of metastasis other than lung;
- •Insufficient organ function, such as severe abnormal hemogram, abnormal liver and kidney function;
- •Any signs of severe or uncontrolled systemic diseases that the researcher believes may have a significant patient risk/benefit balance, including uncontrolled hypertension, severe infection, hepatitis B, hepatitis C and human immunodeficiency virus;
- •History of alcoholism or drug abuse;
- •Pregnant or lactating patients.
研究组 & 干预措施
Cohort 1-Arm A: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA positive
ctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy. ctDNA will be detected after curative treatment and then every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed.
干预措施: Local treatment (Procedure)
Cohort 1-Arm B: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA negative
Subjects with ctDNA negative will undergo routine follow-up. ctDNA will be detected every three months until progression or 2 years.
Cohort 2-Arm C: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA positive
ctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy.
ctDNA is rechecked following treatment. Subjects with ctDNA positive after treatment will receive chemotherapy. Subjects with ctDNA negative after curative treatment will undergo routine follow-up.
After treatment, ctDNA will be detected every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed.
干预措施: Local treatment (Procedure)
Cohort 2-Arm D: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA negative
Subjects with ctDNA negative will undergo routine follow-up. ctDNA will be detected every three months until progression or 2 years.
结局指标
主要结局
Progression-free survival (PFS) in advanced colorectal cancer patients with metastatic small pulmonary nodules under ctDNA guided therapeutic strategies
时间窗: From date of treatment until the date of first documented progression or date of death from any cause, assessed up to 36 months.
次要结局
- The ctDNA clearance rate after local treatment(8 weeks)
- ctDNA positive rate in colorectal cancer patients with metastatic small pulmonary nodules(4 weeks)
- ctDNA positive prediction rate (Consistent with histopathological result as the standard for comparison)(8 weeks)
- The ctDNA clearance rate after chemotherapy in patients achieving NED (Cohort 2)(12 weeks)
研究者
Junjie Peng
MD, PhD
Fudan University