Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.
研究概览
简要总结
The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good options in patients with liver metastases. If the patients have colorectal cancer and never had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If the patient is K-RAS wild type the investigators will add cetuximab. In patients who had received oxaliplatin or in patients with other cancers the investigators will use mitomycin and gemcitabine together with capecitabine.
详细描述
Two regiment are used: N.B. The two regiments will be reported separately
- Mitomycin + Gemcitabine intrahepatic together with Capecitabine. This treatment can be offered patients with solid tumors where all standard treatments have been used. The patients are not allowed to have extrahepatic disease. The purpose of the treatment are to prolonged life.
- FOLFOX where oxaliplatin is given intrahepatic each second time. The treatment are only for patients with colorectal cancer where cure is possible but resection straight ahead is not possible. The patients are allowed to have their colorectal cancer in situ for operation latter on. If the patients are KRAS Wild-type, cetuximab are added.
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
- •liver metastasis
- •solid tumor
排除标准
- •poor performance
研究组 & 干预措施
Mitomycin+Gemcitabine
Intrahepatic treatment, where all standard treatments have been used
干预措施: Oxaliplatin (Drug)
Mitomycin+Gemcitabine
Intrahepatic treatment, where all standard treatments have been used
干预措施: Mitomycin + Gemcitabine (Drug)
结局指标
主要结局
tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.
时间窗: 5 years
次要结局
- Progression free survival, adverse events(5 years)