- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01775280
Response of Hepatic Tumors to Radioembolization (RESRAD)
Radiologic, Histologic and Immunologic Response to Radioembolization of Hepatic Tumors
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
Study Overview
Status
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
ZH
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Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Divisions of Visceral Surgery and Nucelar Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria: - Patients already considered for radioembolization fulfil criteria to be included in the study. If radioembolization is not considered by the tumor board, inclusion in the study should not be considered.
- Non-resectable or borderline resectable liver tumors (HCC, CRCM or CCC) as as-sessed by a multidisciplinary tumor-board. Non-resectability or borderline resectablily is based closeness to essential nonresectable structures (f.e. the portal vein bifurca- tion or hepatic vein trifurcation) or insufficient liver volume after resection, general performance status of the patient.
Chemotherapy (mostly applicable to CRCM) should be termininated at least 4 weeks prior to enrolling patients in the study.
- Concomitant manoevers to manipulate liver volume like portal vein embolization or ligation and two-stage resections are allowed
- Male or female patients 18-99 years of age
- Presentation of the case at the Multidisciplinary Meeting attended by hepatobiliary surgeons, oncologists, hepatologists and radiologists
- Written informed consent given by the patient
- Adequate liver function or kidney function tests, including any of the following. It is possible to perform endoscopic or percutaneous stent placement to achieve normal-isation of laboratory parameters.
- Women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during the 12 months thereaf-ter. A negative pregnancy test before inclusion into the trial is required for women < 50 years. Men who agree not to father a child during participation in the trial or during the 12 months thereafter.
- Effective contraception
Patient compliance and geographic proximity
Exclusion criteria: -Patients with no clinical indications for radioembolization (resectable tumors, no need for downsizing)
- contraindications on ethical grounds,
- women who are pregnant or breast feeding,
- significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardi-ovascular disease, etc) as based on above mentioned labaratory values or preopera-tive cardiac assessment making the patient unsuitable for major surgery known or suspected non-compliance, drug or alcohol abuse, enrolment into a clinical trial within last 4 weeks, extrahepatic tumor burden, as evaluated by PET/CT or chest CT. Potentially resectable small lung nodules or hilar lymphadenopathy by CT or PET in case of MCRC mandate systemic chemotherapy prior to enrolment into this trial if not already performed. The patient may be en-rolled into this trial to be downstaged by radioembolization after finishing systemic chemotherapy.
- Anatomic variant in arteriogram which prevents selective delivery of the chemother-apy to the liver (discussed within group of principal investigators)
- Life expectancy < 3 months
- Candidacy for liver transplantation in the case of HCC
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radioembolization
Radioembolization using Yttrium-90 microspheres using a transarterial approach
|
INjection of Y-90 particles into the hepatic artery using endovascular access
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary endpoint ist the percentage of patients that can be downstaged to resectability
Time Frame: 2012 to 2015
|
2012 to 2015
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histologic response to radioembolization
Time Frame: 2012 to 2015
|
Resected specimen will be examined for changes related to radioembolization like endothelial damage, necrosis, fibrosis
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2012 to 2015
|
Immunological response to radioembolization
Time Frame: 2012 to 2015
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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 |
2012 to 2015
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USZ-ZH-VIS-RESRAD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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