Clinical trial · Interventional
Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
- 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 clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be an effective treatment for liver cancer.
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 |
|---|---|---|---|
| Adult Primary Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ALIAS | 0.90 |
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Localized Unresectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Recurrent Adult Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| TheraSphere | Drug | — | UNRESOLVED |
| yttrium Y 90 glass microspheres | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (yttrium Y 90 glass microspheres)
- description
- Patients receive yttrium Y 90 glass microspheres IA on day 0. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.
- interventionNames
- Radiation: yttrium Y 90 glass microspheres
- Other: laboratory biomarker analysis
- Drug: TheraSphere
Primary outcomes (3)
- measure
- Response to treatment
- timeFrame
- Up to 2 years
- measure
- Survival time
- timeFrame
- Up to 2 years
- measure
- Adverse experiences
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings * Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2 * Life expectancy \>= 3 months * \> 4 weeks since prior radiation, surgery or chemotherapy * Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines * Ineligible for surgical resection Exclusion Criteria: * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times upper limit of normal (UNL) * Serum bilirubin \> 2.0 mg/dl (unless segmental infusion is planned) * Any contraindications to angiography and hepatic artery catheterization such as: * History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated * Bleeding diathesis, not correctable by usual forms of therapy * Severe peripheral vascular disease that would preclude catheterization * Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment * Evidence of pulmonary insufficiency * Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow * Significant extrahepatic disease representing an imminent life-threatening outcome * Active uncontrolled infection * Significant underlying medical or psychiatric illness * Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk * Pregnancy
References
Publications (0)
Data not yet available