Trials / Completed
CompletedNCT02072356
Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 290 (actual)
- Sponsor
- Ohio State University Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 8 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be an effective treatment for liver cancer.
Detailed description
PRIMARY OBJECTIVES: I. Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates. II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment. OUTLINE: Patients receive yttrium Y 90 glass microspheres intra-arterially (IA) on day 0, and may receive a second dose within 30-90 days of initial treatment. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician. After completion of study treatment, patients are followed up at 3-6 weeks and annually for 2 years.
Conditions
- Adult Primary Hepatocellular Carcinoma
- Advanced Adult Primary Liver Cancer
- Localized Unresectable Adult Primary Liver Cancer
- Recurrent Adult Primary Liver Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | yttrium Y 90 glass microspheres | Given Interartrial |
| OTHER | laboratory biomarker analysis | Alpha-fetoprotein assay |
| DRUG | TheraSphere | TheraSphere is delivered into the liver tumor through a catheter placed into the hepatic artery. |
Timeline
- Start date
- 2010-10-11
- Primary completion
- 2021-06-15
- Completion
- 2021-06-15
- First posted
- 2014-02-26
- Last updated
- 2022-09-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02072356. Inclusion in this directory is not an endorsement.