A Phase II Trial of Systemic Chemotherapy (Gemcitabine and Cisplatin) in Combination with Conventional Transarterial Chemoembolization (cTACE) in Patients with Advanced Intra-Hepatic Cholangiocarcinoma (ICC)

What is the purpose of this trial?

Eligible patients enrolled on study will receive a chemotherapy regimen of gemcitabine and cisplatin administered intravenously on Days 1 and 8 of a 21-day cycle. After every 2 cycles of systemic chemotherapy, patients will receive contrast-enhanced MRI to assess liver disease; conventional trans-arterial chemoembolization (TACE) will be performed as indicated based on this assessment. Patients will receive a maximum of 8 cycles of the gemcitabine/cisplatin combination. Up to 3 TACE treatments may be delivered in this same time frame, with the first TACE taking place after 2 cycles of systemic chemotherapy. Following the treatment period, patients will continue clinical follow-up at 3 month intervals until study exit at 18 months post the start of treatment.

It is hypothesized that the addition of conventional transarterial chemoembolization to standard chemotherapy will result in an improvement in PFS in patients with advanced, unresectable ICC, including patients with extra-hepatic disease.


Participation Guidelines

Ages: 18 years and older

Gender: Both


Yale University School of Medicine

Start Date: 01/06/2017

End Date: 12/31/2019

Last Updated: 02/22/2018

Study HIC#: 1603017367