Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Doxorubicin

Liposomal doxorubicin

Chlorotrianisene

Liver Extracts

Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):

Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first

Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):

Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first.

LC Bead

Nicholas Fidelman, MD

TACE is frequently offered to patients with baseline hepatic dysfunction with the purpose of diminishing hepatic tumor burden while patients await transplantation. Without this therapeutic measure, disease may progress beyond UNOS T2 criteria required for organ allocation.

The purpose of the study is to determine whether transarterial chemoembolization using doxorubicin-eluting beads (DEB-TACE) can be used safely and effectively to treat patients with liver-only hepatocellular carcinoma (HCC) and baseline hepatic dysfunction.

TACE Using Doxorubicin-eluting Beads for Patients With HCC and Marginal Hepatic Reserve

Prospective Phase II Study of Chemoembolization With Doxorubicin-Eluting Microspheres for Liver Transplantation Candidates With Hepatocellular Carcinoma and Marginal Hepatic Reserve

Best observed radiographic response rate to Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE) by modified Response Evaluation Criteria in Solid Tumors (mRECIST) was defined as number of patients who had CR, PR, or SD as their best observed response divided by total number of patients with at least one available CT or MRI. Definition of mRECIST for Hepatocellular Carcinoma (HCC). Complete response (CR) = Disappearance of any intratumoral arterial enhancement in all target lesions. Partial response (PR)=At least a 30% decrease in sum of diameters of viable (enhancement in arterial phase) target lesions, taking as reference baseline sum of diameters of target lesions. Stable disease (SD)=Any cases that do not qualify for either partial response or progressive disease. Progressive disease (PD)=An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enh

Number of patients who developed new severe adverse events according to NCI CTCAE version 4.0

Best observed objective radiographic response was defined as the number of patients who had a complete response or partial response divided by total number of evaluable patients.

Measured by mRECIST (see mRECIST definition in the description of the primary objective).

TTUP is defined as time (months) from the first on-study DEB-TACE to development of radiographic disease progression untreatable by liver-directed percutaneous or surgical methods (by mRECIST).

Time to progression was defined as the period of time from the first on-study DEB-TACE to radiographic disease progression at any site by mRECIST.

Time to hepatic progression (TTHP) was defined as a period of time from the first on-study DEB-TACE till development of radiographic evidence of disease progression in the liver by mRECIST.

Progression free survival rate was defined as the number of patients who were alive and free from radiographic progression by mRECIST at pre-defined time periods.

PFS rate was calculated at 3 months, 6 months, 12 months, and 24 months

This measure was defined as the number of patients with alpha-fetoprotein (AFP) response with ≥ 50% decline from baseline (in patients with baseline level ≥ 20) after DEB-TACE.

Left ventricular ejection fraction (LVEF) was measured as percent contraction prior to the first DEB-TACE and 1 month following last planned DEB-TACE. Median LVEF and full range were reported.

Area under curve for doxorubicin concentration in the serum over 7 days was measured by obtaining serum doxorubicin concentration samples at predose, 5 min, 20 min, 40 min, 60 min, 120 min, 6 hours, 24 hours, 7 days time points. A graph of serum doxorubicin concentration over time was then plotted for each of the 17 patients, and the area under the curve for each of the 17 patients was calculated.

Pharmacokinetic sampling was performed only during each of the first planned DEB-TACE procedures.

University of California, San Francisco

Principal Investigator

Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):

Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first

LC Bead: Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):

Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first.

DEB-TACE

Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):

Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first

1st debtace treatment

DEB-TACE #1

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Curt Johanson

Best observed radiographic response for all patients who had at least one follow-up cross-sectional imaging study

Best Observed Radiographic Response Rate (Measured by mRECIST)

Ascites

Edema of limbs

Hepatic failure

Pain

Hyperbilirubinemia

AST elevation

Hyponatremia

Anemia

Thrombocytopenia

Creatinine elevation

Number of Patients Who Developed New Severe Adverse Events

Best Observed Objective Radiographic Response by mRECIST

Time to Untreatable Progression (TTUP)

Time to Progression (TTP)

Time to Hepatic Progression (TTHP)

3 months

6 months

12 months

24 months

Progression Free Survival (PFS) Rate

Proportion of Patients With Alpha-fetoprotein (AFP) Response With ≥ 50% Decline From Baseline

Baseline

1 month following last planned DEB-TACE

Left Ventricular Ejection Fraction (LVEF)

Median Area Under Curve (AUC)

Overall Study

Rare Diseases

Cholangiocarcinoma

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Irinotecan

Carboplatin

Gemcitabine

Cisplatin

Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo

LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo

Gem-Cis or Gem-Carbo

Robert Martin, MD, PhD

The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone.

Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin

Comparative, Prospective, Open-labeled, Randomized Phase II Study of Cisplatin or Carboplatin With Gemcitabine in Combination With Irinotecan-loaded Beads (LC or ONCOZENE) Versus Cisplatin or Carboplatin With Gemcitabine Alone in the Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

Long-term follow-up will occur every 3-4 months for up to one year after discontinuation of active study treatment. Subjects who have completed the long-term follow-up period will be monitored every 3 - 6 months until evidence of progression of disease. Once there is progression of disease subjects will be followed for overall survival by telephone or standard physician follow-ups as per standard of care until death.

University of Louisville

Robert C. Martin

Professor

Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo

LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo

Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo

Gem-Cis or Gem-Carbo alone

Gem-Cis or Gem-Carbo

Randomization to Gem-Cis or Gem-Carbo

Total

All randomized subjects who receive at least one cycle of intravenous chemotherapy or LC or ONCOZENE beads loaded with irinotecan. Subjects will be grouped according to their randomization.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TACE Using Doxorubicin-eluting Beads for Patients With HCC and Marginal Hepatic Reserve	NCT02147301	Hepatocellular ... Chemoembolizati...	LC Bead	18 Years -	University of California, San Francisco
TACE Using Doxorubicin-eluting Beads for Patients With HCC and Marginal Hepatic Reserve	NCT02147301	Hepatocellular ... Chemoembolizati...	LC Bead	18 Years -	University of California, San Francisco
TACE Using Doxorubicin-eluting Beads for Patients With HCC and Marginal Hepatic Reserve	NCT02147301	Hepatocellular ... Chemoembolizati...	LC Bead	18 Years -	University of California, San Francisco
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin	NCT01648023	Unresectable In...	LC or ONCOZENE ... Gem-Cis or Gem-...	18 Years -	University of Louisville
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin	NCT01648023	Unresectable In...	LC or ONCOZENE ... Gem-Cis or Gem-...	18 Years -	University of Louisville

Spots Global Cancer Trial Database for lc bead

Every month we try and update this database with for lc bead cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lc bead

Every month we try and update this database with for lc bead cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lc bead cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.