Downsizing of Unresectable Cholangiocarcinoma by Combined Intravenous and Intra-arterial Chemotherapy
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
An open label, prospective, non-randomized single arm study. Combination of two treatment
modalities - HAI with FUDR and systemic chemotherapy with cisplatin and gemcitabine.
Definition of the maximum tolerated dose (MTD) of intravenous gemcitabine in combination with
intravenous cisplatin and intra-arterial FUDR. Definition of safety and toxicity of this
combined regional and systemic treatment approach. Definition of the response rate after 3
months of hepatic intra-arterial chemotherapy with continuous infusion FUDR with or without
ligation of the right or left portal vein, in combination with 3 months of systemic cisplatin
and gemcitabine in patients with unresectable intrahepatic or hilar CCC.
A total of 9-18 patients are required. 3-6 patients per dose level. A maximum of three dose
levels (1 - 3) has been defined.
Statistical Methodology: Traditional 3+3 dosing algorithm to find MTD.
- Trial with medicinal product