A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®
Completed
Conditions studied: Liver Tumors, Hepatocellular Carcinoma, Hepatoma, Neoplasms
In brief
This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives: 1. Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates. 2. Evaluate patient experience and toxicities associated with TheraSphere® treatment. 3. Measure tumor response rates
Key facts
- Study ID
- NCT00877136
- Run by
- St. Joseph Hospital of Orange
- People needed
- 18
- Starts
- 2009-02-01
- Expected to finish
- 2021-03-01
- Last updated by the study team
- 2021-04-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of hepatocellular carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass with known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis)
- Surgical evaluation must conclude the patient is not a candidate for resection or ablation.
- ECOG Performance Status Score 0 - 2.
- Age 18 years or older.
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.
You may not qualify if…
- Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
- Absolute granulocyte count less than or equal to 1,500/ul
- Uncorrected Platelet count less than or equal to 75,000/ul
- Serum creatinine greater than or equal to 3.0 mg/dl
- Serum bilirubin greater than or equal to 2.0 mg/dl
- Any of the following contraindications to angiography and selective visceral catheterization, 1.)History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, 2.) Bleeding diathesis, not correctable by usual forms of therapy, and/or 3.) Severe peripheral vascular disease that would preclude catheterization.
- Portal hypertension with portal venous shunt away from the liver.
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere® administration; or 2) cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments.
- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
- Significant extrahepatic disease representing an imminent life-threatening outcome.
- Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy).
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness.
- Pregnant women may not participate.
- Children may not participate due to lack of clinical experience.
Where it is running
- The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange — Orange, California, United States
Full record on ClinicalTrials.gov
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