Liver Cancer Clinical Trial
Official title:
A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma
NCT number | NCT01076517 |
Other study ID # | IRB-14324 (NOT RESEARCH) |
Secondary ID | HEP0016 |
Status | Approved for marketing |
Phase | |
First received | |
Last updated |
Verified date | March 2021 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Expanded Access |
To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.
Status | Approved for marketing |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: Patients of any 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 a co-morbid disease or an acute or chronic condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | BTG International Inc. |
United States,
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