ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer: A Prospective Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- 3-year progression-free survival
研究概览
简要总结
The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar.
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 genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
- •Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects);
- •Patients with negative ctDNA after surgery;
- •ASA grade <IV and/or ECOG performance status score ≤ 2;
- •Have sufficient understanding of the study and voluntarily sign an informed consent form.
排除标准
- •Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;
- •Patients with a history of other malignancies;
- •Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;
- •Patients who are allergic to any component in the study;
- •Patients who have received other tumor-related investigational drug therapy;
- •Patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases;
- •Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases that require comprehensive treatment (including mental disorders), and serious abnormal laboratory tests;
- •Patients with a history of severe mental illness;
- •Pregnant or lactating women;
- •Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.
研究组 & 干预措施
Watching and waiting group
Watch and Wait strategy is one of the treatment strategies of advanced rectal cancer, which recommends no immediate surgery with close surveillance.
干预措施: Colorectal cancer resection combined with liver metastasis resection. (Procedure)
Adjuvant chemotherapy group
Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
干预措施: Colorectal cancer resection combined with liver metastasis resection. (Procedure)
Adjuvant chemotherapy group
Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
干预措施: FOLFOX chemotherapy regimen (Drug)
结局指标
主要结局
3-year 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.
5-year 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.
次要结局
- 3-year overall survival(5 years after operation.)
- Complications(5 years.)
研究者
Yanxin Luo,MD
Principal Investigator
Sixth Affiliated Hospital, Sun Yat-sen University