TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma

Status:

APPROVED_FOR_MARKETING

TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma

Lead Sponsor:

University of California, Irvine

Collaborating Sponsors:

BTG International Inc.

Conditions:

Hepatocellular Carcinoma

Liver Cancer

Eligibility:

All Genders

18+ years

Brief Summary

The purpose of this protocol is to provide TheraSphere treatment for patients with liver cancer who cannot be treated by surgery. The effect on the tumor and any side effects of TheraSphere treatment ...

Detailed Description

This protocol provides TheraSphere treatment for patients with liver cancer who cannot be treated by surgery. Patients with hepatocellular carcinoma will be evaluated for eligibility for this treatmen...

Eligibility Criteria

Inclusion

Confirmed diagnosis of intrahepatic carcinoma. 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 Alpha-fetoprotein assay (AFP) (clinical diagnosis).
The cancer must be unresectable.
Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
Age ≥ 18 years.
Able to comprehend and read the study information sheet in accordance with institutional and federal guidelines.

Exclusion

Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
Absolute granulocyte count ≤ 1,500/ul
Platelet count ≤ 75,000/μl
Serum creatinine ≥ 2.0 mg/dl
Serum bilirubin ≥ 2.0 mg/dl
Any of the following contraindications to angiography and selective visceral catheterization:
History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
Bleeding diathesis, not correctable by usual forms of therapy
Severe peripheral vascular disease that would preclude catheterization.
Portal hypertension with portal venous shunt away from the liver.
Evidence of potential delivery of greater than 16.5 millicurie (mCi) (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere administration; or 2) cumulative delivery of radiation to the lungs \> 30 Gy over multiple treatments.
Evidence of any detectable Tc-99m 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.
Significant underlying medical or psychiatric illness.
Pregnant women may not participate.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00906984

Last Update

January 8 2024

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