Adjuvant Chemotherapy Combined With Targeted Therapy Versus Adjuvant Chemotherapy Alone in the Treatment of Stage T3-4N2 Colorectal Cancer:A Multicenter, Randomized, Phase III Clinical Trail
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- 5-year disease-free survival
研究概览
简要总结
The goal of this clinical trial] is to compare in resectable stage T3-4N2 colorectal cancer. The main question it aims to answer is: whether the use of targeted therapy in combination with adjuvant chemotherapy is associated with improved disease-free survival (DFS) 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 sexes, aged 18-75 years;
- •Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery;
- •ASA grade < IV and/or ECOG performance status score ≤ 2 points;
- •Fully understand and voluntarily sign the informed consent form for this study.
排除标准
- •A history of other malignant tumors;
- •Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy;
- •Patients allergic to any component in the study;
- •Patients with severe uncontrollable recurrent infections or other severe uncontrollable 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 requiring comprehensive treatment (including mental illness), and severe abnormalities in laboratory tests;
- •Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
- •Patients with a history of severe mental illness;
- •Pregnant or lactating women;
- •Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.
研究组 & 干预措施
Combining targeted therapy group
Adjuvant chemotherapy with targeted therapy
干预措施: FOLFOX chemotherapy regimens (Drug)
Combining targeted therapy group
Adjuvant chemotherapy with targeted therapy
干预措施: Bevacizumab (Drug)
Single adjuvant chemotherapy group
Adjuvant chemotherapy alone
干预措施: FOLFOX chemotherapy regimens (Drug)
结局指标
主要结局
5-year disease-free survival
时间窗: 5 years after operation.
median of disease-free survival
时间窗: 5 years after operation.
3-year disease-free survival
时间窗: 3 years after operation.
disease-free survival (DFS) is defined as the time from the date of surgery for colorectal cancer to the occurrence of tumor recurrence or metastasis, or death from any cause.
次要结局
- 3-year overall survival(3 years after recruited.)
- Complications(5 years after recruited.)
- 5-year overall survival(5 years after recruited.)
研究者
Yanxin Luo,MD
Principal Investigator
Sixth Affiliated Hospital, Sun Yat-sen University