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

18 Years
Open (Enrolling)
Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasm, Primary Liver Cancer

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Trial Information

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

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 treatment with the following: physical examination, medical history, blood tests
requiring approximately 2 tablespoons of blood, EKG, CT or MR of chest to examine lungs, CT
or magnetic resonance (MR) of abdomen to evaluate liver, stomach and intestines, and bone
scan to rule out spread of disease to bones. If eligible on initial screening, patients will
proceed to a second stage of screening, including an hepatic angiogram to confirm treatment
can be provided safely and to highlight the blood vessels supplying the liver, and a nuclear
medicine study (Tc-99m MAA scan) to display the blood flow to the lungs, stomach and

When it is determined treatment can be delivered safely, patients will receive TheraSphere
via the hepatic artery through blood vessels supplying the liver on an outpatient basis.

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 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 Criteria:

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The protocol allows for prospective collection of data. There is no randomization to an alternative form of therapy. However, we measure tumor response after treatment based on CT scans and tumor markers.

Outcome Time Frame:

Every 3-6 months

Safety Issue:


Principal Investigator

David K Imagawa, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Irvine


United States: Food and Drug Administration

Study ID:

UCI 01-61



Start Date:

May 2002

Completion Date:

December 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Liver Neoplasm
  • Primary Liver Cancer
  • Hepatocellular carcinoma
  • Liver cancer
  • Primary liver cancer
  • Unresectable liver cancer
  • Unresectable hepatocellular carcinoma
  • TheraSphere
  • Neoplasms
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Chao Family Comprehensive Cancer Center Orange, California  92868