Trial Outcomes & Findings for The LC Bead Trial; Transarterial Chemoembolization of Hepatocellular Carcinoma (HCC)With a Drug-eluting Bead (NCT NCT01259024)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.

Results posted on

2018-05-15

Participant Flow

Participant was screened and recruited on 1/5/2012

Single-arm study - participant received 1st trans-arterial chemoembolization treatment on 1/23/2012, second treatment on 2/20/2012, and third treatment on 3/20/12. Physician decision to withdraw participant on 4/12/2012 due to denial of CMS reimbursement.

Participant milestones

Participant milestones
Measure	Doxorubicin-eluting LC Bead transarterial chemoembolization using doxorubicin-eluting LC Beads 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.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Doxorubicin-eluting LC Bead transarterial chemoembolization using doxorubicin-eluting LC Beads 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.
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxorubicin-eluting LC Bead n=1 Participants transarterial chemoembolization using doxorubicin-eluting LC Beads 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.

Population: One participant was enrolled on this IDE and was treated on protocol for 14 weeks. After being made aware that CMS would not provide reimbursement, the PI decided to withdraw the patient and continued to treat off protocol.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.

Population: 1 patient was enrolled in the study, but was withdrawn by the PI due to inability to obtain CMS reimbursement. The patient was treated off protocol and therefore there are no study results to be analyzed.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.

Population: 1 participant was enrolled, analyzed was 0.

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.

Outcome measures

Outcome data not reported

Adverse Events

Doxorubicin-eluting LC Bead

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Doxorubicin-eluting LC Bead n=1 participants at risk transarterial chemoembolization using doxorubicin-eluting LC Beads 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.
General disorders fatigue	100.0% 1/1 • Number of events 1 • 14 weeks, then participant was withdrawn
Injury, poisoning and procedural complications right groin burning pain	100.0% 1/1 • Number of events 1 • 14 weeks, then participant was withdrawn
General disorders back pain	100.0% 1/1 • Number of events 2 • 14 weeks, then participant was withdrawn
Gastrointestinal disorders anorexia	100.0% 1/1 • Number of events 2 • 14 weeks, then participant was withdrawn
Gastrointestinal disorders nausea	100.0% 1/1 • Number of events 1 • 14 weeks, then participant was withdrawn

Additional Information

Patricia Nieters, RN, BSN, Clinical Research Specialist

Washington University

Phone: 314-362-3371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place