Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- 5-years Progression Free Survival
研究概览
简要总结
The goal of this clinical trial is to compare in resectable liver metastases colorectal cancer patients.The main question it aims to answer is to investigate whether the progression-free survival (PFS) of resectable colorectal liver metastasis (CRLM) patients with positive ctDNA after surgery is superior with the combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both males and females, aged 18-75 years;
- •Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have been treated with ablation achieving similar R0 resection effect);
- •Postoperative ctDNA-positive patients;
- •ASA grade < IV and/or ECOG performance status score ≤ 2;
- •Participants must have a full understanding of the study and voluntarily sign an informed consent form.
排除标准
- •Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.
- •Patients with a history of other malignant tumors.
- •Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.
- •Patients who are allergic to any component of the study.
- •Patients who have received other tumor-related investigational drug treatments.
- •Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.
- •Patients with other factors that may affect the study results or lead to early termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe laboratory abnormalities.
- •Patients with a history of severe mental illness.
- •Pregnant or lactating women.
- •Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.
研究组 & 干预措施
Adjuvant chemotherapy combined with maintenance therapy
干预措施: Colorectal resection surgery. (Procedure)
Adjuvant chemotherapy combined with maintenance therapy
干预措施: FOLFOX chemotherapy regimen (Drug)
Adjuvant chemotherapy combined with maintenance therapy
干预措施: Capecitabine (Drug)
Single adjuvant chemotherapy
干预措施: Colorectal resection surgery. (Procedure)
Single adjuvant chemotherapy
干预措施: FOLFOX chemotherapy regimen (Drug)
结局指标
主要结局
5-years Progression Free Survival
时间窗: 5 years after operation.
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
3-years Progression Free Survival
时间窗: 3 years after operation.
PFS is defined as the time from randomization to the occurrence of any progression or death from any cause.
次要结局
- Complication(5 years.)
- 3-years overall survival(3 years after operation.)
- 5-years overall survival(5 years after operation.)
研究者
Yanxin Luo,MD
Principal Investigator
Sixth Affiliated Hospital, Sun Yat-sen University