drugset / Trial / NCT02807181

SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

NCT02807181

Phase 2/3 Terminated 89 enrolled Sirtex Medical
RandomizedParallel-groupOpen-labelTreatment

Summary

The study planned to evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients were randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients were randomized to CIS-GEM alone.

Timeline

Start
2017-02-14
Primary completion
2021-04-29
Completion
2021-04-29

Drugs

EvaluationDrugModalityDoseRoute
Background Cisplatin Other / unclassified 25 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous