NCT00866944已完成2 期
A Randomized, Open-label, Controlled, Multi-center Phase II Study to Evaluate the Efficacy and Safety of Adecatumumab Alone or Sequentially to FOLFOX Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 16
- 主要终点
- Disease free survival rate (DFS)
研究概览
简要总结
The purpose of this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed complete resection (R0) of liver metastases from colorectal adenocarcinoma
- •Age ≥18 years
- •ECOG performance status ≤ 2
- •Patient was informed, has read and understood the patient information / informed consent form and has given written informed consent
排除标准
- •Extra-hepatic distant metastases or locally recurrent disease at time of enrolment
- •Neoadjuvant chemotherapy of liver metastases prior to surgery
- •Any anticancer chemotherapy within 4 weeks prior to study entry
- •Start of Oxaliplatin-based chemotherapy within 9 months prior to study entry
- •Any biological anticancer therapy or immunotherapy within 4 weeks prior to study entry
- •Any radiotherapy or radio frequency ablation (RFA) to the liver prior to surgery
- •Treatment with any investigational product within a time range of 4-5 half-lives (t½) prior to study entry
- •Acute or chronic pancreatitis or history of alcohol induced pancreatitis
- •Liver cirrhosis, acute hepatitis or chronic hepatic disease
- •Any unresolved complications from prior surgery
- •Persistent neuropathy
- •History of other malignancy within 5 years prior to study start, with the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix and Ductal Carcinoma in Situ (DCIS)
- •History of inflammatory bowel disease
- •Active severe infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
- •Use of immune-suppressive agents such as the regular use of systemic corticosteroids
- •HIV positivity
- •Known hypersensitivity or intolerability to immunoglobulins in general, other recombinant human or humanized antibodies, Folinic Acid, 5-Fluorouracil, Oxaliplatin or a component of the study drug formulations, known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Pregnant or nursing women
- •Women of childbearing potential or male patients not willing to use an effective form of contraception during treatment phase of the study and at least 6 months thereafter
- •Not willing or incapable to comply with all study visits and assessments
- •Placed into an institution due to juridical or regulatory ruling
研究组 & 干预措施
1
Experimental
Adecatumumab alone
干预措施: Adecatumumab (Drug)
2
Experimental
FOLFOX 4 followed by Adecatumumab
干预措施: Adecatumumab and FOLFOX (Drug)
3
Active Comparator
FOLFOX 4 alone
干预措施: FOLFOX 4 (Drug)
结局指标
主要结局
Disease free survival rate (DFS)
时间窗: 1 year
次要结局
- time to relapse(1 year)
- Incidence of AEs(1 year)
- Quality of Life(1 year)
研究者
研究点 (16)
Loading locations...
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