A Prospective, Randomized, One-center Study Comparing Hepatic Arterial Infusion Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Colorectal Cancer Liver Metastases
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- conversional resection rates
研究概览
简要总结
To date no prospective trials have been completed that demonstrated whether HAI is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine conversional resection rates and survival for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.
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
- •All patients must meet the following criteria:
- •Patients must have histologically confirmed incurable CRLM and no clinical or radiographic evidence of extrahepatic disease
- •Patients is medically eligible to receive HAI, as determined by the MDT (multidisciplinary team)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- •Age > 18 years
- •Subject life expectancy > 3 months
- •Platelets > 100×103/mm3
- •Total bilirubin <1.5mg/dl
- •Creatinine level < 2.0 mg/dl
- •All patients must sign an informed consent form
排除标准
- •The CRLM is amenable to curative surgical therapy
- •Prior radiation, TACE or HAI to the liver
- •Uncorrectable coagulopathy
- •Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival
- •Current or planned treatment with any experimental chemotherapy or target drugs
研究组 & 干预措施
Arm A
HAI plus chemotherapy ± target therapy
干预措施: HAI (Drug)
Arm A
HAI plus chemotherapy ± target therapy
干预措施: chemotherapy ± target therapy (Drug)
Arm B
chemotherapy ± target therapy
干预措施: chemotherapy ± target therapy (Drug)
结局指标
主要结局
conversional resection rates
时间窗: 2-4 months
次要结局
- overall response rates(6 months)