NCT02807181

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

Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Sirtex Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical study was 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 were to be followed until death, withdrawal of consent, or until end of study.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin-gemcitabine	Systemic chemotherapy
DEVICE	Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)	SIR-Spheres microspheres followed by systemic chemotherapy

Timeline

• Start date: 2017-02-14
• Primary completion: 2021-04-29
• Completion: 2021-04-29
• First posted: 2016-06-21
• Last updated: 2025-05-09
• Results posted: 2025-05-09

Locations

23 sites across 8 countries: United States, Australia, Belgium, France, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated device study