Clinical trial · Observational
Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
A Humanitarian Device Exemption Use 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)
RATIONALE: 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 effective treatment for liver cancer that cannot be removed by surgery. PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| yttrium Y 90 glass microspheres | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Patient Completion
- timeFrame
- Through study completion, up to 24 months or when patient discontinues treatment for whatever reason.
- description
- Proportion of patients completing scheduled treatment plan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Confirmed diagnosis of intrahepatic carcinoma * Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass AND known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP * Unresectable disease * No portal hypertension with portal venous shunt away from the liver * No significant extrahepatic disease representing an imminent life-threatening outcome * No evidence of potential delivery of \> 16.5 mCi (30 Gy absorbed dose) radiation to the lungs on either of the following: * First yttrium Y 90 glass microspheres (TheraSphere®) administration * Cumulative delivery of radiation to the lungs over multiple treatments PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0-2 * Absolute granulocyte count ≥ 1,500/μL * Platelet count \> 25,000/μL * Serum creatinine \< 2.0 mg/dL (unless using non-iodinated contrast or on dialysis) * Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin and the tumor may be isolated from a vascular standpoint, treatment may proceed) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception Exclusion criteria: * Any of the following contraindications to angiography and selective visceral catheterization: * History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographic techniques * Bleeding diathesis, not correctable by usual forms of therapy * Severe peripheral vascular disease that would preclude catheterization * Evidence of any detectable Tc-99 macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow * Severe liver dysfunction or pulmonary insufficiency * Active uncontrolled infection * Significant underlying medical or psychiatric illness PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior and no other concurrent anticancer therapy
References
Publications (1)
- RESULTSalem R, Lewandowski RJ, Mulcahy MF, Riaz A, Ryu RK, Ibrahim S, Atassi B, Baker T, Gates V, Miller FH, Sato KT, Wang E, Gupta R, Benson AB, Newman SB, Omary RA, Abecassis M, Kulik L. Radioembolization for hepatocellular carcinoma using Yttrium-90 microspheres: a comprehensive report of long-term outcomes. Gastroenterology. 2010 Jan;138(1):52-64. doi: 10.1053/j.gastro.2009.09.006. Epub 2009 Sep 18. PMID 19766639