Intra-hepatic and systemic chemotherapy with or without antibody for patients with non-resectable liver metastasis from solid tumours

Herlev University Hospital0 个研究点目标入组 100 人开始时间: 2011年5月13日最近更新: 2017年7月24日

适应症

试验速览

暂无简介。

•Informed consent
•Age > 18 years
•Performance status 0-1; expected survival = 3 months
•Patient with histologically verified malignity
•Liver metastases not suitable for surgery or other local treatment
•Present of liver metastases must be documented by CT/PET-CT-scan. Extrahepatic disease should be excluded except for patients with colorectal cancer. In patients with colorectal cancer the patients must have limited extrahepatic disease if the extrahepatic disease is stable in four month or potentially resectable.
•Measurable disease (RECIST 1.1)
•Metastases < 70 % of the liver
•Neutrofile granulocytes ? 1.5 x 109/l and thrombocytes ? 100 x 109/l
•Bilirubine ? 2.0 x UNL (upper normal limit).
•Creatinine-clearence ? 30 ml/min.
•INR < 1.6
•Intrahepatic treatment can be accomplished
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Other current or prior malignant disease in the past five years, except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
•Cytotoxic or experimental treatment within a 14 days period before start of trial medication
•The patient is not allowed to participate in other clinical trials.
•Other severe medical conditions
•Severe cardial disease or AMI < 1 year
•Presence of diseases preventing oral therapy
•Patients with uncontrolled infection
•Pregnant or lactating women
•Women capable of childbearing not using a sufficient method of birth control
•Patients not able to understand the treatment or to collaborate
•Prior serious or unsuspected reaction after treatment with fluorpyrimidin
•Known prior hypersensitivity reactions to the agents
•Interstitial pneumonitis or pulmonary fibrosis

发起方

Herlev University Hospital