TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

Study Overview
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Brief Summary
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Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.

Detailed Description
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Therasphere consists of glass microspheres containing a radioactive material called Yttrium-90. Therasphere is delivered into the liver tumor through a catheter placed into the hepatic artery which is the artery that provides the main blood supply to the tumor, this way delivering the radioactive material directly to the tumor and sparing the rest of the liver tissue from radiation.

Official Title
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A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis

Conditions
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Liver Cancer, Portal Vein Thrombosis

Intervention / Treatment
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* Device: TheraSphere


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 yrs of age or older Diagnosis of Hepatocellular Carcinoma Portal Vein Thrombosis ECOG performance < 2 ->4 weeks since prior radiation, surgery or chemotherapy. Life expectancy > 3 months Able to provide written informed consent process in accordance with institutional review boards guidelines. Exclusion Criteria: Contraindications to angiography and selective visceral catheterization. Evidence of blood flow to the lung from the liver greater than 16.5 mCi 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. Significant extrahepatic disease. Severe liver disfunction of 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therasphere<br> | Device: TheraSphere<br>* TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.<br>* Other names: There are no other names for this device.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate to the administration of Therasphere |  | Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival for patients with unresectable liver cancer. | Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year. | Participants will be followed through 1 year after receiving treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, portal vein thrombosis, HCC