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The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma

Phase 2
18 Years
Open (Enrolling)
Liver Cancer

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Trial Information

The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma


- Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients
with unresectable hepatocellular carcinoma.

- Determine the response in patients with unresectable hepatocellular carcinoma treated
with hepatic arterial infusion of yttrium-90 glass microspheres.

- Determine the toxic effects and adverse experiences associated with this therapy in
these patients.

- Determine the survival time of patients treated with this therapy.

- Determine the time to progression of disease in the liver, duration of response, and
progression-free interval of patients treated with this therapy.

- Evaluate the influence of pretreatment characteristics on efficacy parameters in
patients treated with this therapy.

- Assess the quality of life of patients treated with this therapy.

OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused
directly into a liver tumor in order to kill tumor cells and cause less damage to the normal
tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is
accessed through the femoral artery in the groin. This procedure is generally completed on
an outpatient basis. Patients may receive a single dose to the whole liver, or sequential
treatments to each side of the liver approximately 30 to 90 days apart. Patients may be
re-treated at a later time.

Patients are followed every 2 to 4 months for the rest of their lives to access tumor
progression, symptom management and quality of life.

Inclusion Criteria


- Confirmed diagnosis of hepatocellular carcinoma (HCC)

- Histopathology confirmation may be waived in patients with a radiographically
identifiable liver mass in addition to known laboratory or clinical risk factors
for HCC, and/or an elevated alpha-fetoprotein (AFP) level

- No significant extrahepatic disease that may represent an imminent life-threatening

- No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of
radiotherapy to the lungs on either the first yttrium-90 glass microspheres
(TheraSphere®) administration or with cumulative delivery of radiation to the lungs
over multiple treatments due to any angiographically uncorrectable flow to the
gastrointestinal tract


- ECOG performance status 0-2

- No hepatic dysfunction

- Bilirubin ≤ 2.0 mg/dL

- No vascular abnormalities or severe peripheral vascular disease that would preclude
angiography or selective visceral catheterization

- No pulmonary insufficiency

- No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the
stomach or duodenum after application of established angiographic techniques to stop
such flow

- No contraindications to angiography

- No contraindications to selective visceral catheterization

- No other condition or cormorbidity that would preclude study treatment

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 30 days
after study


- At least 1 month since prior chemotherapy, radiotherapy, or surgery

- No other concurrent investigational agents or anticancer therapy for HCC

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response to treatment

Safety Issue:


Principal Investigator

T. Clark Gamblin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UPMC Cancer Center at UPMC Presbyterian



Study ID:




Start Date:

August 2000

Completion Date:

Related Keywords:

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



UPMC Liver Cancer Center Pittsburgh, Pennsylvania  15213