Response of Hepatic Tumors to Radioembolization (RESRAD)
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|ClinicalTrials.gov Identifier: NCT01775280|
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : January 24, 2013
Last Update Posted : June 9, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Liver Metastasis||Radiation: Injection of Ytttrium-90 microspheres into the hepatic artery||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiologic, Histologic and Immunologic Response to Radioembolization of Hepatic Tumors|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
Radioembolization using Yttrium-90 microspheres using a transarterial approach
Radiation: Injection of Ytttrium-90 microspheres into the hepatic artery
INjection of Y-90 particles into the hepatic artery using endovascular access
- Primary endpoint ist the percentage of patients that can be downstaged to resectability [ Time Frame: 2012 to 2015 ]
- Histologic response to radioembolization [ Time Frame: 2012 to 2015 ]Resected specimen will be examined for changes related to radioembolization like endothelial damage, necrosis, fibrosis
- Immunological response to radioembolization [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775280
|University Hospital Zurich, Divisions of Visceral Surgery and Nucelar Medicine|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Erik Schadde, MD||University Hospital Zurich, Division of Visceral and Transplant Surgery|
|Principal Investigator:||Niklaus Schaefer, MD||University Hospital Zurich, Division of Nuclear Medicine|