Chemotherapy with gemcitabine, capecitabine, irinotecan and bevacizumab to patients with cholangiocarcinoma after progression on first line treatment.

Herlev University Hospital0 个研究点目标入组 50 人开始时间: 2013年6月7日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•Inclusion criteria
•Informed consent
•Age > 18 years
•Performance status 0-1
•Patient with histological cholangiocarcinoma or malign cells and a CT-scan in accordance to a cholangiocarcinoma.
•Liver metastases not suitable for surgery or other local treatment
•Have received first line treatment for cholangiocarcinoma.
•Neutrofile granulocytes ? 1.5 x 109/l and thrombocytes ? 75 x 109/l
•Bilirubine ? 2.0 x UNL (upper normal limit).
•Creatinine-clearence ? 30 ml/min
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 35

•Exclusion criteria
•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.
•The patient is not allowed to participate in other clinical trials with antineoplastic treatment..
•Other severe medical conditions
•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
•Known prior hypersensitivity reactions to the agents

发起方

Herlev University Hospital