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A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol

Phase 2
18 Years
Not Enrolling
Liver Cancer

Thank you

Trial Information

A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol



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

- Evaluate patient experience and toxicities associated with TheraSphere® treatment.

- Enter treatment experience into a liver database.


- Determine the tumor response rates in patients receiving this treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic
arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.

After completion of study therapy, patients are followed for 30 days and then annually
thereafter for up to 2 years.

Inclusion Criteria:

- Confirmed diagnosis of hepatocellular carcinoma

- Surgical evaluation by a member of the Liver Tumor Program must conclude the patient
is not a candidate for resection or ablation

- Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2

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

Exclusion Criteria:

- Absolute granulocyte count =<1,500/ul

- Platelet count =<75,000/ul

- Serum creatinine >= 2.0 mg/dl

- Serum bilirubin * >= 2.0 mg/dl for bilateral treatment or lobar treatment * > 3.0
mg/dl for single lesion which could be treated by segmental fusion

- 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 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 > 30 Gy over multiple treatments

- Evidence of any detectable Tc-99m MMA 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 (Childs' Classification C) or pulmonary insufficiency
(requiring continuous oxygen therapy)

- Active uncontrolled infection

- Significant underlying medical or psychiatric illness

- Pregnant women may not participate

- Children 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:

Access to treatment

Outcome Time Frame:

24 months after last treatment

Safety Issue:


Principal Investigator

Yi-Jen Chen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

Related Keywords:

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



City of Hope Medical Center Duarte, California  91010