Patients with hepatocellular carcinoma often die from intrahepatic disease since current treatment options are generally limited. Local treatment using holmium radioembolization could offer an effective treatment and a more personal approach than yttrium radioembolization (standard-of-care) as holmium has more imaging options.
Primary objective: • To establish the safety and toxicity profile of holmium radioembolization in patients with hepatocellular carcinoma. Secondary objectives: * To evaluate efficacy of holmium radioembolization in hepatocellular carcinoma without curative treatment options in a non-comparative phase II study. * To evaluate tumor marker response. * To evaluate Quality of Life (QoL). * To evaluate biodistribution / dosimetry. * To evaluate hepatic function. Study design: Multi-center, interventional, treatment, non-randomized, open label, non-comparative, early phase II study. The study is a collaboration between UMC Utrecht and Erasmus MC Rotterdam. Recruitment and treatment of patients will take place in both centers. Intervention: Holmium radioembolization will be performed via a catheter during angiography.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
An intra-arterial radioembolization procedure will be performed. The hepatic artery catheter is inserted via the femoral or radial artery under x-ray guidance by a trained interventional radiologist. The radiologist must repeatedly check the position of the catheter during the procedure to ensure it remains correctly sited and that reflux of the QuiremSpheres® into other organs does not occur. This is performed by injecting contrast medium. At the conclusion of the procedure, the catheter is removed.
Erasmus Medical Center
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Safety, expressed as the rate of unacceptable toxicity.
Safety, expressed as the rate of unacceptable toxicity, which is the occurrence of RE-induced liver disease, defined as a total bilirubin increase grade 3 or higher according to the CTCAE version 4.03, in combination with ascites and low albumin, in the absence of disease progression
Time frame: Up to 6 months
Tumor response based on radiologic assessment of MRI scans using mRECIST
Tumor response based on radiologic assessment of MRI scans using mRECIST
Time frame: Up to 6 months
Changes in tumor marker alpha-fetoprotein
Changes in tumor marker alpha-fetoprotein
Time frame: Up to 6 months
Quality of Life (QoL) using EORTC C30
Quality of Life (QoL) using EORTC C30
Time frame: Up to 6 months
Quality of Life (QoL) using EORTC HCC18
Quality of Life (QoL) using EORTC HCC18
Time frame: Up to 6 months
Quality of Life (QoL) using BPI-SF
Quality of Life (QoL) using BPI-SF
Time frame: Up to 6 months
Biodistribution/dosimetry based on quantitative assessment of MRI scans
Biodistribution/dosimetry based on quantitative assessment of MRI scans
Time frame: Up to 6 months
Changes in hepatic function as determined by hepatobiliary scintigraphy
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Changes in hepatic function as determined by hepatobiliary scintigraphy
Time frame: Up to 3 months