Response of Hepatic Tumors to Radioembolization

Phase 2

Withdrawn

• Conditions: Hepatocellular Carcinoma; Liver Metastasis; Intrahepatic Cholangiocarcinoma
• Interventions: Radiation: Injection of Ytttrium-90 microspheres into the hepatic artery

• Registration Number: NCT01775280
• Lead Sponsor: University of Zurich

Brief Summary

The study enrolls patients with non-resectable or borderline resectable hepatocellular carcinoma (HCC), intraheaptic choalngiocarcinoma (IHCC) or colorectal cancer metastasis. Patients are not a candidates for liver transplantation and have only limited extrahepatic disease. All patients are treated with radioembolization. Primary endpoint is the percentage of patients that can be downstaged to resectability.

Secondary endpoints are radiologic response to radioembolization,tissue response to radiomembolization and systemic immune response and intra-tumoral T-cell response to radioembolization.

* Trial with radiotherapy

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-24
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radioembolization	Injection of Ytttrium-90 microspheres into the hepatic artery	Radioembolization using Yttrium-90 microspheres using a transarterial approach

Primary Outcome Measures

Name	Time	Method
Primary endpoint ist the percentage of patients that can be downstaged to resectability	2012 to 2015

Secondary Outcome Measures

Name	Time	Method
Histologic response to radioembolization	2012 to 2015	Resected specimen will be examined for changes related to radioembolization like endothelial damage, necrosis, fibrosis
Immunological response to radioembolization	2012 to 2015	Circulating T-cells and tissue based T-cells will be examined for their response to tumor antigens, clonal proliferation.; Serologic response to tumor antigens will be examined

Trial Locations

Locations (1)

University Hospital Zurich, Divisions of Visceral Surgery and Nucelar Medicine; 🇨🇭 Zurich, ZH, Switzerland