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A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

18 Years
Open (Enrolling by invite only)
Hepatocellular Carcinoma

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Trial Information

A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

The objectives of this study are to provide supervised access to treatment with TheraSphere
to eligible patients with Hepatocellular Carcinoma of the liver who are not surgical
resection candidates and to evaluate patient experience, toxicities and overall survival
associated with TheraSphere treatment.

This is an observational treatment use protocol that will provide IRB oversight and
documentation of the clinical experience of patients undergoing treatment for liver
carcinoma using TheraSphere. Participation involves no investigational or research
procedures. Patients will be followed for treatment-related adverse experiences and will be
monitored in accordance with institutional practices. Approximately 60 patients will be
enrolled in a treatment protocol and the number may be expanded following completion of the
first cohort. The total number of patients to be treated will be determined based on
clinical experience and patient outcomes. There are no control subjects in this treatment

The duration of the protocol will depend on patient experience with this treatment. An
initial one year approval is sought at this time. Patient experience will be evaluated
continuously and if the clinicians find that the treatment provides benefits to patients,
renewal of the approval will be sought after the first 12 months.

Inclusion Criteria:

- 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 AFP (clinical diagnosis).

- The cancer must be unresectable.

- ECOG Performance Status Score 0-2

- Age greater than or equal to 18

- Able to comprehend and provide written informed consent in accordance with
institutional and federal guidelines.

Exclusion Criteria:

- Any pre-treatment lab findings within 15 days of treatment demonstrating: absolute
granulocyte count less than or equal to 1,500/ul, platelet count less than or equal
to 45,000/ul, serum creatinine greater than or equal to 3.0 mg/dl, serum bilirubin
greater than or equal to 4.0 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 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 > 30Gy 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.

Type of Study:


Study Design:

Observational Model: Case-Only

Outcome Measure:

Progression of liver cancer

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

David A Iannitti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Carolinas Medical Center


United States: Institutional Review Board

Study ID:

HDE# 980006



Start Date:

January 2008

Completion Date:

January 2009

Related Keywords:

  • Hepatocellular Carcinoma
  • Unresectable HCC
  • Carcinoma
  • Carcinoma, Hepatocellular