Trial Outcomes & Findings for LC Drug Eluting Bead for Treatment of Liver Cancer Which Cannot be Surgically Removed (NCT NCT00877071)

Results Overview

Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to both a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant as well as those individuals within Milan criteria as an attempt to maintain their eligibility.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

36 months

Results posted on

2016-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	LC Drug Eluting Bead, Regional Chemoembolization Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	LC Drug Eluting Bead, Regional Chemoembolization Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation
Overall Study disease progression	2

Baseline Characteristics

LC Drug Eluting Bead for Treatment of Liver Cancer Which Cannot be Surgically Removed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LC Drug Eluting Bead, Regional Chemoembolization n=2 Participants Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation
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	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Population: The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.

Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to both a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant as well as those individuals within Milan criteria as an attempt to maintain their eligibility.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.

Outcome measures

Outcome data not reported

Adverse Events

LC Drug Eluting Bead, Regional Chemoembolization

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LC Drug Eluting Bead, Regional Chemoembolization n=2 participants at risk Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation
General disorders hiccoughs	50.0% 1/2 • Number of events 1
Gastrointestinal disorders constipation	50.0% 1/2 • Number of events 1
Gastrointestinal disorders rectal bleeding	50.0% 1/2 • Number of events 1
Gastrointestinal disorders diarrhea	50.0% 1/2 • Number of events 1
General disorders fever	50.0% 1/2 • Number of events 1

Additional Information

Dr. David Geller

University of Pittsburgh Medical Center

Phone: 412-692-2001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place