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

NCT02147301 | Terminated Results DMC

• 1 other identifier: 124520
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; Chemoembolization

Outcome Measures

Primary Outcomes (2)

• Best Observed Radiographic Response Rate (Measured by mRECIST)

  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

  1 year

• Number of Patients Who Developed New Severe Adverse Events

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

  1 year

Secondary Outcomes (8)

• Best Observed Objective Radiographic Response by mRECIST

  6 months

• Time to Untreatable Progression (TTUP)

  1 year

• Time to Progression (TTP)

  1 year

• Time to Hepatic Progression (TTHP)

  1 year

• Progression Free Survival (PFS) Rate

  3 months, 6 months, 12 Months, and 24 months

Study Arms (1)

DEB-TACE

EXPERIMENTAL

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

Device: LC Bead

Interventions

LC Bead DEVICE

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.

Also known as: DC Bead

DEB-TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female patients, age 18 years of age or older
• Diagnosis of liver-only HCC based on European Association for the Study of the Liver (EASL) criteria (radiographic lesion appearance on contrast-enhanced CT or MRI, i.e. enhancement on early arterial phase, washout on portal venous phase with or without associated elevation of serum alpha-fetoprotein (AFP) level \>200 Units Per Millilitre (U/ml)) or histologic confirmation of HCC diagnosis, whichever is applicable.
• UNOS stage T1, T2, or T3 disease.
• Candidates for liver transplantation (listed or screened) according to one of the following criteria:
• Milan criteria (one lesion \< 5cm or 3 or fewer lesions each \< 3cm),
• UCSF Downstaging criteria (one lesion less than 8 cm or 2-3 lesions each less than 5 cm with sum of maximum dimensions less than 8 cm, or 4-5 lesions each less than 3 cm with sum of maximum dimensions less than 8 cm)
• University of California, San Francisco (UCSF) All-Comers criteria (UNOS stage T3 disease beyond UCSF Downstaging Criteria).
• At least one measurable site of disease in the liver according to RECIST version 1.1 and odified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
• At least one of the following clinical, laboratory, or imaging parameters:
• Mild or moderate ascites
• Serum bilirubin ≥ 3 mg/dl but less than 6 mg/dl
• Aspartate aminotransferase (AST) \> 5 times upper limit of normal (ULN) but \< 10 times ULN
• Alanine aminotransferase (ALT) \> 5 times upper limit of normal (ULN) but \< 10 times ULN
• International normalized ratio for prothrombin time (INR) \>1.5 but ≤ 2.5
• Portal vein thrombosis (branch or main)

You may not qualify if:

• Liver-directed therapy (chemoembolization, radioembolization, bland embolization, ablative therapy) within 4 weeks of DEB-TACE.
• Previous liver transplantation.
• Serum bilirubin ≥ 6 mg/dl
• AST \> 10 times upper normal limit
• ALT \> 10 times upper normal limit
• INR \> 2.5
• Serum creatinine \> 1.5 mg/dl
• Macrovascular tumor invasion of portal and/or hepatic vein(s)
• Extracapsular tumor extension
• Extrahepatic disease
• Hepatic encephalopathy refractory to medical therapy
• Active uncontrolled infection
• Imaging evidence of common bile duct obstruction
• Previous sphincterotomy or bilio-enteric anastomosis
• Significant hepatic arterial to portal vein shunting in the area to be treated.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Curt Johanson
• Organization: University of California, San Francisco

curt.johanson@ucsf.edu

415-353-2310

Study Officials

• Nicholas Fidelman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 26, 2014
• Study Start: December 17, 2014
• Primary Completion: January 27, 2017
• Study Completion: April 5, 2017
• Last Updated: September 10, 2019
• Results First Posted: September 10, 2019

Record last verified: 2019-08

Locations

US (1)