Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
Cholangiocarcinoma is a relatively rare disease. In Denmark approximately 150 patients are
diagnosed each year. A small part of the patients can be offered surgery, but the operation
will rarely be radical, and most patients with cholangiocarcinoma are therefore candidates
In Denmark the combination therapy of Gemcitabine, Oxaliplatin and Capecitabine has been
used in recent years. Based on experience with gastrointestinal tumors, however, there seems
to be an effect of new biological substances, including EGFR antibodies. There are casuistic
reports on the specific effect of a monoclonal antibody against EGFR in cholangiocarcinoma.
The effect of EGF is mediated through an intracellular pathway involving the KRAS protein.
It has been shown that a mutation of KRAS causes the EGF system to be constantly activated.
Effect in patients with a KRAS mutation is therefore not to be expected. Approximately 50%
of the patients present this mutation.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
Up to 6 months
Denmark: National Board of Health