NCT03379844

HEPAR Primary: Holmium-166-radioembolization in Hepatocellular Carcinoma Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatocellular Carcinoma
• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-21
• Primary completion: 2020-01-01
• Completion: 2021-08-01
• First posted: 2017-12-20
• Last updated: 2022-11-08

Locations

2 sites across 1 country: Netherlands