Clinical trial · Observational
TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma
A Humanitarian Device Exemption Treatment Protocol of Therasphere for the 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)
TheraSphere is a medical device containing yttrium-90 (Y-90) a radioactive material that has been used to treat liver tumors. When Y-90 is put into very tiny glass beads (TheraSphere), it can be injected into the liver through a blood vessel. This allows a large local dose of radiation to be delivered to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TheraSphere | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- TheraSphere
- interventionNames
- Radiation: TheraSphere
Primary outcomes (1)
- measure
- Response to Treatment
- timeFrame
- Through 24 months post-treatment
- description
- Diagnostic imaging studies for assessment of tumor response will be performed according to usual standard of care as established by the referring oncologist. The principal clinician will be able to get a preliminary evaluation of tumor response in patients who return for subsequent treatment, as part of the imaging studies required for repeat safety screening of patients.
Secondary outcomes (2)
- measure
- Safety
- timeFrame
- Through 24 months post-treatment or death
- description
- Evaluate toxicities and adverse experiences associated with TheraSphere treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of the liver * Patients who are able to give informed consent, will be eligible. * Patients must have an ECOG Performance Status score of \< or = 2 * Must have 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 chemotherapy Exclusion Criteria: * Contraindications to angiography and selective visceral catheterization * Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) per treatment 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 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.
References
Publications (0)
Data not yet available