Response of Hepatic Tumors to Radioembolization

Hepatocellular Carcinoma Clinical Trial

— RESRAD  

Official title:

Radiologic, Histologic and Immunologic Response to Radioembolization of Hepatic Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01775280
• Other study ID #: USZ-ZH-VIS-RESRAD
• Status: Withdrawn
• Phase: Phase 2
• First received: January 22, 2013
• Last updated: June 8, 2015
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: June 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Hepatocellular Carcinoma
• Intrahepatic Cholangiocarcinoma
• Liver Metastasis
• Liver Neoplasms

Intervention

Radiation:
• Injection of Ytttrium-90 microspheres into the hepatic artery
INjection of Y-90 particles into the hepatic artery using endovascular access

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Divisions of Visceral Surgery and Nucelar Medicine	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint ist the percentage of patients that can be downstaged to resectability		2012 to 2015	No
Secondary	Histologic response to radioembolization	Resected specimen will be examined for changes related to radioembolization like endothelial damage, necrosis, fibrosis	2012 to 2015	No
Secondary	Immunological response to radioembolization	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	No