The LC Bead Trial; Transarterial Chemoembolization of Hepatocellular Carcinoma (HCC)With a Drug-eluting Bead

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Patients will be given IV fluids and premedication with 500 mg metronidazole, 10 mg dexamethasone, and 8 mg ondansetron to prevent infection, limit pain and nausea. The femoral artery will be accessed and a catheter advanced into the superior mesenteric artery. Positioning of all catheters will be confirmed by injection of radiographic contrast material. Superior mesenteric angiography will be performed with images obtained through the portal venous phase to confirm patency and flow direction of the portal vein and determine the presence of aberrant supply to the right lobe of the liver by the superior mesenteric artery. The catheter will then be advanced into the celiac artery. Celiac angiography will be performed to determine remainder of the hepatic arterial anatomy. Selection of the tumor bearing artery will then be performed with a microcatheter which is advanced through the catheter in the celiac artery origin. Selection will be guided by fluoroscopy and will be at the lobar level or peripherally in all cases. Once the feeding vessel has been selected and confirmed by contrast injection, the physician will initiate embolization with LC Beads. Up to two vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared. The LC Beads will be mixed with radiographic contrast to ensure fluoroscopic visibility during injection. Under careful fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery reaches stasis prior to administration of both vials, the residual volume of LC Beads will be noted on the surgical report form. If after administration of the DEB, there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization. After confirming that the artery is appropriately treated, all catheters and guidewires will be removed from the femoral artery and hemostasis obtained.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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doxorubicin-eluting LC Bead

transarterial chemoembolization using doxorubicin-eluting LC Beads

Group Type EXPERIMENTAL

transarterial chemoembolization using a drug-eluting bead

Intervention Type DEVICE

Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization.

Interventions

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transarterial chemoembolization using a drug-eluting bead

Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization.

Intervention Type DEVICE

Other Intervention Names

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TACE DEB TACE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes