Clinical trial · Interventional
The LC Bead Trial; Transarterial Chemoembolization of Hepatocellular Carcinoma (HCC)With a Drug-eluting Bead
Hepatic Arterial Embolization of Hepatocellular Carcinoma With a Doxorubicin Eluting Bead
NCT01259024CI-TRIAL-00032918terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): inability to obtain CMS approval
Summary
Brief summary (as posted)
This study involves the combined use of the FDA approved device, LC Bead and the FDA approved drug, Doxorubicin for the treatment of primary hepatocellular carcinoma (HCC). The current indication of the LC Bead is for the embolization of hypervascular tumors and arteriovenous malformations. The study is designed to establish if drug eluting beads are more effective and less toxic than standard chemoembolization treatment.
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 |
|---|---|---|---|
| transarterial chemoembolization using a drug-eluting bead | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- doxorubicin-eluting LC Bead
- description
- transarterial chemoembolization using doxorubicin-eluting LC Beads
- interventionNames
- Device: transarterial chemoembolization using a drug-eluting bead
Primary outcomes (3)
- measure
- To Collect Data on Patients With Hepatocellular Carcinoma (HCC) Being Treated With Chemoembolization With Doxorubicin Eluting Beads (DEB).
- timeFrame
- Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.
- description
- 4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 * Patent main portal vein with hepatopetal flow * Bilirubin less than or equal to 2.5 mg/dl, albumin \>2.8g/dl, alkaline phosphatase \<630IU/L, AST \<235IU/L, ALT \<265IU/L, INR \<2.0, PTT \<40sec., absolute neutrophil count \>1K/cumm, platelet count \>100K/cumm * No encephalopathy * No previous biliary ductal intervention * Child A status * Confirmation of Hepatocellular Carcinoma (through biopsy or radiological exam) * Unresectable HCC and ineligible for possible curative therapies * Normal ECG with QT \<480 msec within the previous 2 months * Normal MUGA scan within the previous 2 months * Measureable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) * Subject is competent and willing to provide written informed consent in order to participate in the study Exclusion Criteria: * Thrombosis or hepatofugal flow in the main portal vein; presence of a large shunt which in the operator's opinion precludes embolization * Replacement of greater than 50% of the liver parenchyma by tumor * Bilirubin greater than or equal to 2.6 mg/dl * ECOG performance status of 2 or greater * Previous liver directed therapy * Previous biliary intervention (excluding cholecystectomy) * Allergy to iodinated contrast used for angiography * Elevated creatinine greater than or equal to 1.8 mg/dl * Women who are pregnant or nursing * Patients in which any of the following are contraindicated: 1)the use of doxorubicin, 2)MRI or CT scans, 3) Hepatic embolization procedures * Patients with active bacterial or fungal infection that is deemed to be clinically significant by the investigator * Patients with cardiac disease, including congestive heart failure, recent myocardial infarction, or uncontrolled arrhythmias * Non-English speaking patients
References
Publications (4)
- BACKGROUNDDhanasekaran R, Kooby DA, Staley CA, Kauh JS, Khanna V, Kim HS. Comparison of conventional transarterial chemoembolization (TACE) and chemoembolization with doxorubicin drug eluting beads (DEB) for unresectable hepatocelluar carcinoma (HCC). J Surg Oncol. 2010 May 1;101(6):476-80. doi: 10.1002/jso.21522. PMID 20213741
- BACKGROUNDBiselli M, Andreone P, Gramenzi A, Trevisani F, Cursaro C, Rossi C, Ricca Rosellini S, Camma C, Lorenzini S, Stefanini GF, Gasbarrini G, Bernardi M. Transcatheter arterial chemoembolization therapy for patients with hepatocellular carcinoma: a case-controlled study. Clin Gastroenterol Hepatol. 2005 Sep;3(9):918-25. doi: 10.1016/s1542-3565(05)00425-8. PMID 16234031
- BACKGROUNDMalagari K, Pomoni M, Kelekis A, Pomoni A, Dourakis S, Spyridopoulos T, Moschouris H, Emmanouil E, Rizos S, Kelekis D. Prospective randomized comparison of chemoembolization with doxorubicin-eluting beads and bland embolization with BeadBlock for hepatocellular carcinoma. Cardiovasc Intervent Radiol. 2010 Jun;33(3):541-51. doi: 10.1007/s00270-009-9750-0. Epub 2009 Nov 24. PMID 19937027
- BACKGROUNDNamur J, Wassef M, Millot JM, Lewis AL, Manfait M, Laurent A. Drug-eluting beads for liver embolization: concentration of doxorubicin in tissue and in beads in a pig model. J Vasc Interv Radiol. 2010 Feb;21(2):259-67. doi: 10.1016/j.jvir.2009.10.026. PMID 20123210