HEPAR Primary: Holmium-166-radioembolization in Hepatocellular Carcinoma Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03379844|
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Hepatocellular Carcinoma Non-resectable||Device: Holmium-166 radioembolization||Phase 2|
• To establish the safety and toxicity profile of holmium radioembolization in patients with hepatocellular carcinoma.
- 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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Holmium-166-radioembolization in Patients With Unresectable Hepatocellular Carcinoma (HCC); a Multi-center, Interventional, Non-randomized, Non-comparative, Open Label, Early Phase II Study: HEPAR Primary|
|Actual Study Start Date :||August 21, 2017|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||August 1, 2021|
|Experimental: Holmium-166 radioembolization||
Device: Holmium-166 radioembolization
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.
- Safety, expressed as the rate of unacceptable toxicity. [ Time Frame: Up to 6 months ]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
- Tumor response based on radiologic assessment of MRI scans using mRECIST [ Time Frame: Up to 6 months ]Tumor response based on radiologic assessment of MRI scans using mRECIST
- Changes in tumor marker alpha-fetoprotein [ Time Frame: Up to 6 months ]Changes in tumor marker alpha-fetoprotein
- Quality of Life (QoL) using EORTC C30 [ Time Frame: Up to 6 months ]Quality of Life (QoL) using EORTC C30
- Quality of Life (QoL) using EORTC HCC18 [ Time Frame: Up to 6 months ]Quality of Life (QoL) using EORTC HCC18
- Quality of Life (QoL) using BPI-SF [ Time Frame: Up to 6 months ]Quality of Life (QoL) using BPI-SF
- Biodistribution/dosimetry based on quantitative assessment of MRI scans [ Time Frame: Up to 6 months ]Biodistribution/dosimetry based on quantitative assessment of MRI scans
- Changes in hepatic function as determined by hepatobiliary scintigraphy [ Time Frame: Up to 3 months ]Changes in hepatic function as determined by hepatobiliary scintigraphy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379844
|Contact: Trial Officeemail@example.com|
|Erasmus Medical Center||Not yet recruiting|
|Rotterdam, Netherlands, 3015CN|
|Contact: Renée Leenaars +31107033612 firstname.lastname@example.org|
|Principal Investigator: Adriaan Moelker, MD, PhD|
|University Medical Center Utrecht||Recruiting|
|Utrecht, Netherlands, 3584 CX|
|Contact: Tjitske Kent-Bosma +31887551321 email@example.com|
|Principal Investigator: Marnix G. Lam, MD, PhD|
|Principal Investigator:||Marnix G. Lam, MD, PhD||UMC Utrecht|