A Prospective Study on the Conversion Therapy of Ras / BRAF Wild Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases: Standard Chemotherapy Plus Cetuximab VS. Standard Chemotherapy Plus Bevacizumab
试验速览
- 阶段
- 3 期
- 入组人数
- 584
- 主要终点
- Conversion liver resection rate
研究概览
简要总结
The prognosis of patients with metastatic right-sided colon cancer is worse than that of patients with metastatic left-sided cancer. Different guidelines have different recommendations on specific conversion therapy for colorectal liver metastases. The United States NCCN guidelines do not recommend standard chemotherapy combined with anti EGFR monoclonal antibody for patients with right colon cancer. The European ESMO guidelines recommend that patients with Ras / BRAF wild-type right-sided colon cancer should first consider three drugs ± bevacizumab, but considering the objective response rate results, standard chemotherapy + anti EGFR monoclonal antibody is still one of the choices. China CSCO guidelines recommend standard chemotherapy ± bevacizumab, and also recommend standard chemotherapy + cetuximab for patients with right-sided colon cancer.
Therefore, the targeted therapy for RAS / BRAF wild-type metastatic right colon cancer is still controversial. Therefore, we are ready to carry out the clinical trial of cetuximab and bevacizumab in conversion therapy for RAS / BRAF wild-type metastatic right colon cancer. The conversion resection rate is the primary point, and the objective response rate, perioperative safety and long-term survival are the secondary points.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The primary tumor was confirmed by histology as colorectal adenocarcinoma
- •primary right-sided colorectal adenocarcinoma
- •Radiologic evidence suggests that the initial unresectable liver metastases
- •RAS/BRAF gene wild-type states
- •ECOG was 0 ~ 1
- •Life expectancy ≥ 3 months
- •Good hematological function: neutrophil ≥ 1.5x109/l and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization)
- •Normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization);
- •Sign the written informed consent to participate in the experiment
排除标准
- •Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy
- •Known or suspected extrahepatic metastasis
- •Patients with known hypersensitivity to any component of the study treatment
- •Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range
- •Acute or subacute intestinal obstruction
- •Pregnancy (no pregnancy confirmed by serum / urine β - hCG) or breastfeeding.
- •She had other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer
- •Known drug / alcohol abuse
- •No legal capacity or limited legal capacity
- •There is peripheral neuropathy
研究组 & 干预措施
standard chemotherapy plus Bevacizumab
干预措施: mFOLFOX/FOLFIRI ( Standard Chemotherapy) (Drug)
standard chemotherapy plus Cetuximab
干预措施: Cetuximab (Drug)
standard chemotherapy plus Cetuximab
干预措施: mFOLFOX/FOLFIRI ( Standard Chemotherapy) (Drug)
standard chemotherapy plus Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Conversion liver resection rate
时间窗: up to 6 months
Rate of conversion from initially unresectable liver metastases to resectable ones
次要结局
- objective response rate(up to 6 months)
- Progression free survival(up to 3 years)
- Incidence of adverse events(up to 6 months)
- overall survival(up to 5 years)