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Radiologic, Histologic and Immunologic Response to Radioembolization of Hepatic Tumors

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Liver Metastasis

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Trial Information

Radiologic, Histologic and Immunologic Response to Radioembolization of Hepatic Tumors

Inclusion Criteria

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

2012 to 2015

Safety Issue:


Principal Investigator

Erik Schadde, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Zurich, Division of Visceral and Transplant Surgery


Switzerland: Swissmedic

Study ID:




Start Date:

October 2012

Completion Date:

October 2015

Related Keywords:

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