TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: TheraSphere HUD

• Registration Number: NCT00683631
• Lead Sponsor: University of Louisville

Brief Summary

The purpose of this protocol is to provide access to Therasphere treatment for patients with liver tumors.

Detailed Description

Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with primary liver cancer (hepatocellular carcinoma (HCC)). Unfortunately, most of these patients present with disease that is not amenable to surgery (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15% of HCC patients are suitable surgical candidates. The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to cancerous tissue in the liver of patients with HCC. This type of regional therapy may have several advantages over systemically administered treatments and may also be of value as a 'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2021-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

• Patients over 18 years of age, of any race or sex, who have histologic proof of primary cancer to the liver, who are able to give informed consent, will be eligible.
• Patients must have an ECOG Performance Status score of greater than or equal to 2, with a life expectancy of > 3 months, non-pregnant with an acceptable contraception in premenopausal women.
• The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis).
• Participation in the TheraSphere Registry.

Exclusion Criteria

• Contraindications to angiography and selective visceral catheterization
• Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs
• Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
• Significant extrahepatic disease representing an imminent life-threatening outcome
• Severe liver dysfunction or pulmonary insufficiency
• Active uncontrolled infection
• Pregnancy
• Refusal to participate in the TheraSphere Registry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TheraSphere	TheraSphere HUD	TheraSphere

Trial Locations

Locations (1)

University of Louisville Hospital / Norton Hospital; 🇺🇸 Louisville, Kentucky, United States