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

18 Years
Open (Enrolling)
Liver Cancer

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Trial Information

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


- Provide supervised access to treatment with yttrium Y 90 glass microspheres
(TheraSphere®) to eligible patients with cancer of the liver who are not candidates for
surgical resection.

- Evaluate patient experience and toxicities associated with yttrium Y 90 glass
microspheres (TheraSphere®) treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through
a percutaneously placed catheter into the hepatic artery. 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 at 2 weeks, 30 days, and then
once a year for approximately 2 years.

Inclusion Criteria


- Confirmed diagnosis of intrahepatic carcinoma

- Histopathology confirmation may be waived in patients with a radiographically
identifiable liver mass AND known laboratory or clinical risk factors for cancer
or elevated tumor markers such as AFP

- Unresectable disease

- No portal hypertension with portal venous shunt away from the liver

- No significant extrahepatic disease representing an imminent life-threatening outcome

- No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) radiation to
the lungs on either of the following:

- First yttrium Y 90 glass microspheres (TheraSphere®) administration

- Cumulative delivery of radiation to the lungs over multiple treatments


Inclusion criteria:

- ECOG performance status 0-2

- Absolute granulocyte count ≥ 1,500/μL

- Platelet count > 25,000/μL

- Serum creatinine < 2.0 mg/dL (unless using non-iodinated contrast or on dialysis)

- Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin and
the tumor may be isolated from a vascular standpoint, treatment may proceed)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

Exclusion criteria:

- Any of the following contraindications to angiography and selective visceral

- History of severe allergy or intolerance to any contrast media, narcotics,
sedatives, or atropine, that cannot be controlled using basic angiographic

- Bleeding diathesis, not correctable by usual forms of therapy

- Severe peripheral vascular disease that would preclude catheterization

- Evidence of any detectable Tc-99 macroaggregated albumin flow to the stomach or
duodenum, after application of established angiographic techniques to stop such flow

- Severe liver dysfunction or pulmonary insufficiency

- Active uncontrolled infection

- Significant underlying medical or psychiatric illness


- At least 4 weeks since prior and no other concurrent anticancer therapy

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Proportion of patients completing scheduled treatment plan

Outcome Time Frame:

At point that patient discontinues treatment for whatever reason.

Safety Issue:


Principal Investigator

Riad Salem, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Food and Drug Administration

Study ID:

NU 1365-001



Start Date:

December 2004

Completion Date:

January 2016

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611