Unresectable Intrahepatic Cholangiocarcinoma Clinical Trial
Official title:
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)
The study will be a single-center, single-arm, Phase II study of gemcitabine and cisplatin in combination with conventional trans-arterial chemoembolization therapy in adult patients with advanced ICC. 25 patients will be enrolled over the course of 2 years, with an additional 1.5 years for patient follow-up.
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.
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