Response of Hepatic Tumors to Radioembolization

NCT01775280 | Withdrawn Phase 2

• 1 other identifier: USZ-ZH-VIS-RESRAD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Primary endpoint ist the percentage of patients that can be downstaged to resectability

  2012 to 2015

Secondary Outcomes (2)

• Histologic response to radioembolization

  2012 to 2015

• Immunological response to radioembolization

  2012 to 2015

Study Arms (1)

Radioembolization

EXPERIMENTAL

Radioembolization using Yttrium-90 microspheres using a transarterial approach

Radiation: Injection of Ytttrium-90 microspheres into the hepatic artery

Interventions

Injection of Ytttrium-90 microspheres into the hepatic artery RADIATION

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

Radioembolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• Effective contraception
• Patient compliance and geographic proximity

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Divisions of Visceral Surgery and Nucelar Medicine

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Erik Schadde, MD

  University Hospital Zurich, Division of Visceral and Transplant Surgery

  PRINCIPAL INVESTIGATOR

• Niklaus Schaefer, MD

  University Hospital Zurich, Division of Nuclear Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 24, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

CH (1)