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A Humanitarian Device Exemption Treatment Protocol of Therasphere for the Treatment of Unresectable Hepatocellular Carcinoma

18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

A Humanitarian Device Exemption Treatment Protocol of Therasphere for the Treatment of Unresectable Hepatocellular Carcinoma

Surgical resection of the affected portion of the liver offers the best chance for
disease-free survival in patients with hepatoma (HCC). Unfortunately, most hepatoma
patients present with disease that is not amenable to resection (multifocal disease) or have
other medical contraindications to surgery (limited hepatic reserve related to advanced
cirrhosis or chronic hepatitis). Fewer than 15%1 of hepatoma patients are suitable surgical

The objective of treatment with TheraSphere is to selectively administer a potentially
lethal dose of radioactive material to neoplastic tissue in the liver of patients with HCC.
Regional therapies for HCC may have several advantages over systemically administered
treatments. Irradiating a cancer prior to treatment with regional chemotherapy may be more
effective than either therapeutic modality alone. TheraSphere may also be of value as a
'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.

Inclusion Criteria:

- Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma
of the liver

- Patients who are able to give informed consent, will be eligible.

- Patients must have an ECOG Performance Status score of < or = 2

- Must have a life expectancy of > 3 months

- Non-pregnant with an acceptable contraception in premenopausal women

- Patients must be > 4 weeks since prior radiation or prior surgery and at least 1
month post chemotherapy

Exclusion Criteria:

- Contraindications to angiography and selective visceral catheterization

- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) per
treatment of radiation to the lungs

- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after
application of established angiographic techniques to stop or mitigate such flow (ex.
placing catheter distal to gastric vessels)

- Significant extrahepatic disease representing an imminent life-threatening outcome

- Severe liver dysfunction or pulmonary insufficiency

- Active uncontrolled infection

- Significant underlying medical or psychiatric illness

- Pregnancy

- Patients will be excluded if they have pre-existing diarrhea/illness, or if they have
a co-morbid disease or condition that would preclude safe delivery of TheraSphere
treatment and place the patient at undue risk.

Type of Study:


Study Design:

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

Outcome Measure:

Response to Treatment

Outcome Description:

Diagnostic imaging studies for assessment of tumor response will be performed according to usual standard of care as established by the referring oncologist. The principal clinician will be able to get a preliminary evaluation of tumor response in patients who return for subsequent treatment, as part of the imaging studies required for repeat safety screening of patients.

Outcome Time Frame:

Through 24 months post-treatment

Safety Issue:


Principal Investigator

Susan Littman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

October 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Unresectable
  • Hepatocellular Carcinoma
  • TheraSphere
  • Yttrium-90
  • Carcinoma
  • Carcinoma, Hepatocellular



Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541