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


N/A
N/A
N/A
Open (Enrolling)
Both
Liver Cancer

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Trial Information

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


Inclusion Criteria:



Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of
the liver, and who are able to give informed consent, will be eligible. Patients must
have an ECOG Performance Status score of £ 2, with 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 other chemotherapy.

Exclusion Criteria:

- Contraindications to angiography and selective visceral catheterization

- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) 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:

Expanded Access

Study Design:

N/A

Principal Investigator

Daniel Yung-Ho Sze

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

XHEP0016-NOT-RESEARCH

NCT ID:

NCT01076517

Start Date:

December 2008

Completion Date:

December 2099

Related Keywords:

  • Liver Cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Stanford University School of MedicineStanford, California  94305-5317