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

Hepatocellular Carcinoma Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Hepatocellular Carcinoma Non-resectable

• NCT number: NCT03379844
• Study type: Interventional
• Source: UMC Utrecht
• Status: Completed
• Phase: Phase 2
• Start date: August 21, 2017
• Completion date: August 1, 2021