Clinical trial · Observational
A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®
NCT00877136CI-TRIAL-00051102completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatoma | Hepatocellular Carcinoma | ALIAS | 0.90 |
| Liver Tumors | Liver Neoplasm | ALIAS | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TheraSphere® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Number of patients given access to treatment with TheraSphere.
- timeFrame
- 24 months
- description
- The number of eligible patients provided with supervised access to treatment with TheraSphere with primary cancer to the liver who are not surgical resection candidates.
- measure
- Evaluate patient experience with Therasphere.
- timeFrame
- 24 months
- description
- Evaluation of patient experience and toxicities associated with Therasphere via patient follow-ups with clinician notes.
Secondary outcomes (1)
- measure
- Tumor response to treatment with TheraSphere®
- timeFrame
- 24 Months
- description
- Diagnostic imaging studies for assessment of tumor response will be performed according to usual standard of care as established by the referring oncologist.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: 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.
References
Publications (0)
Data not yet available
No reference posted for this study.