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

  • STATUS
    Recruiting
  • End date
    Jun 12, 2021
  • participants needed
    180
  • sponsor
    Sirtex Medical
Updated on 4 November 2020
Investigator
Fabio Niccolini
Primary Contact
Macquarie University Hospital (1.3 mi away) Contact
+45 other location
platelet count
kidney function tests
gemcitabine
cholangiocarcinoma
unresectable intrahepatic cholangiocarcinoma

Summary

The study will 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 will be randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients will be randomized to CIS-GEM alone.

Description

This clinical study is a prospective, multicenter, randomized, controlled study evaluating SIR-Spheres Y-90 resin microspheres followed by cisplatin-gemcitabine (CIS-GEM) chemotherapy vs. CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma.

Randomized patients will be followed until death, withdrawal of consent, or until end of study.

Details
Treatment Cisplatin-gemcitabine, Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)
Clinical Study IdentifierNCT02807181
SponsorSirtex Medical
Last Modified on4 November 2020

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