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

NCT02807181 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-05-09

Study results available
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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.

Conditions

  • Intrahepatic Cholangiocarcinoma

Interventions

DRUG

Cisplatin-gemcitabine

Systemic chemotherapy

DEVICE

Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)

SIR-Spheres microspheres followed by systemic chemotherapy

Sponsors & Collaborators

  • Sirtex Medical

    lead INDUSTRY

Principal Investigators

  • Jordi Bruix, MD · Head of the Hepatic Oncology Unit, Hospital Clinic

  • Harpreet Wasan, MD · Imperial College Healthcare Hammersmith Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2021-04-29
Completion
2021-04-29
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807181 on ClinicalTrials.gov