Chemoembolisation With Irinotecan Loaded DC Bead (DEBIRI) in Combination With Cetuximab and 5FU/LV in the First Line Treatment of Patients With KRAS Wildtype Metastatic Colorectal Cancer (mCRC)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Feasibility of chemoembolization with DC Bead loaded with Irinotecan
研究概览
简要总结
The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for wildtype KRAS unresectable liver metastases from colorectal cancer.
详细描述
20 patients will be included. The duration of the trial will be approximately 24 months.
Every 8 weeks there will be a tumour lesion assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of stage IV KRAS wild-type colorectal adenocarcinoma, with metastases predominantly in the liver (≥80% of tumor burden) that are deemed unresectable.
- •Primary tumour has been treated with complete surgical resection without evidence of residual tumour
- •Patients must have at least 1 measurable lesion (RECIST criteria)
- •Performance status ECOG 0-1
- •Aged ≥18 years
- •Life expectancy > 3 months
- •No prior chemotherapy for metastatic disease
- •Hematologic function: WBC ≥ 3.0 x 10*9/L, platelets ≥ 100 x10*9/L
- •Adequate organ function as measured by:
- •Serum creatinine £ 1.5 x upper limit of normal (ULN)
- •Serum transaminases (AST & ALT) £ 5 x ULN
- •Bilirubin> 1.5 times the upper limit of the normal range
- •Women of child bearing potential and fertile men are required to use effective contraception (negative βHCG for women of child-bearing age)
- •Signed, written informed consent
- •Patients with patent main portal vein
- •Maximum liver involvement ≤60%
排除标准
- •Presence of CNS metastases
- •Contraindications to FU/LV, Irinotecan or Cetuximab
- •Active bacterial, viral or fungal infection within 72 hours of study entry
- •Women who are pregnant or breast feeding
- •Allergy to contrast media or history of severe hypersensitivity to study drugs.
- •Presence of another concurrent malignancy. Prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- •Any contraindication for hepatic embolization procedures:
- •porto-systemic shunt
- •hepatofugal blood flow
- •severe atheromatosis
- •Contraindication to hepatic artery catheterization, such as a patient with severe peripheral vascular disease precluding catheterization
- •Other significant medical or surgical condition, or any medication or treatment regimens, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation
研究组 & 干预措施
Chemoembolization
chemoembolization with DC Bead™ loaded with Irinotecan
干预措施: 5 FU (Drug)
Chemoembolization
chemoembolization with DC Bead™ loaded with Irinotecan
干预措施: DC Bead™ (Device)
Chemoembolization
chemoembolization with DC Bead™ loaded with Irinotecan
干预措施: Cetuximab (Drug)
Chemoembolization
chemoembolization with DC Bead™ loaded with Irinotecan
干预措施: Irinotecan (Drug)
结局指标
主要结局
Feasibility of chemoembolization with DC Bead loaded with Irinotecan
时间窗: after one cycle = after 8 weeks
Feasibility of the study by measuring the number of enrolled patients who can finish the first cycle of treatment
次要结局
- progression-free survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months)
研究者
Prof. Dr. Eric Van Cutsem
Professor MD PhD Eric Van Cutsem
Universitaire Ziekenhuizen KU Leuven