Response of Hepatic Tumors to Radioembolization

NCT ID: NCT01775280

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-10-31

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

Conditions

Hepatocellular Carcinoma; Intrahepatic Cholangiocarcinoma; Liver Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radioembolization

Radioembolization using Yttrium-90 microspheres using a transarterial approach

Group Type: EXPERIMENTAL

Injection of Ytttrium-90 microspheres into the hepatic artery

Intervention Type: RADIATION

INjection of Y-90 particles into the hepatic artery using endovascular access

Interventions

Injection of Ytttrium-90 microspheres into the hepatic artery

INjection of Y-90 particles into the hepatic artery using endovascular access

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Schadde, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Visceral and Transplant Surgery

Niklaus Schaefer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Nuclear Medicine

Locations

University Hospital Zurich, Divisions of Visceral Surgery and Nucelar Medicine

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

USZ-ZH-VIS-RESRAD

Identifier Type: -

Identifier Source: org_study_id