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TACE With or Without SBRT as Bridging Therapy for Pre-transplant HCC Patients

Primary Purpose

Hepatocellular Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TACE transarterial chemoembolization
stereotatic body radiotherapy (SBRT)
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient capable of giving informed consent
  • Patient diagnosed with hepatocellular carcinoma and listed or recommended to be listed for orthotopic liver transplantation at the participating institution
  • Age > 18 years old
  • Meets clinical criteria for eligibility for TACE to the target lesion per Interventional Radiology
  • Childs' Class A or B7
  • Eastern Clinical Oncology Group performance status 0 or 1

Exclusion Criteria:

  • Prior radiotherapy to the upper abdomen or radioembolization of the liver
  • Prior TACE to the target lesion, RFA, or liver transplant
  • Active GI bleed within 2 weeks of study enrollment
  • Active GI ulcer disease within 4 weeks of study enrollment
  • Ascites refractory to medical therapy
  • Contraindication to receiving radiotherapy or TACE
  • Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
  • Contraindication to both contrast enhanced MRI and contrast enhanced CT (i.e. unable to undergo follow-up imaging or SBRT treatment planning)
  • Women who are pregnant
  • Participation in another concurrent treatment protocol

Sites / Locations

  • Loyola University Medical Center
  • Oregon Health & Science University
  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

A -Tace alone

B - Tace combined with SBRT

Arm Description

A - TACE alone (control group, current practice and treatment)

B- TACE combined with SBRT (experimental group).

Outcomes

Primary Outcome Measures

Progression Free Survival
endpoint is OLT

Secondary Outcome Measures

Full Information

First Posted
August 7, 2013
Last Updated
January 9, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Loyola University, Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01918683
Brief Title
TACE With or Without SBRT as Bridging Therapy for Pre-transplant HCC Patients
Official Title
A Pilot Trial of Transarterial Chemoembolization With or Without Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
Loyola University, Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial is designed to be the initial prospective pilot investigation of the effectiveness of combined SBRT and TACE as bridging therapy for HCC patients awaiting liver transplanation. No prospective clinical trials regarding the combination of TACE and SBRT in pre-transplant population have been performed. We propose the trial be conducted as a pilot clinical trial with the goal of enrolling 40 patients into each arm
Detailed Description
The purpose of this study is to determine whether the combination of stereotatic body radiotherapy (SBRT) tand transarterial chemoembolization (TACE) is an effective "bridging therapy" for patients hepatocellular carcinoma (HCC) of the liver awaiting transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A -Tace alone
Arm Type
Other
Arm Description
A - TACE alone (control group, current practice and treatment)
Arm Title
B - Tace combined with SBRT
Arm Type
Experimental
Arm Description
B- TACE combined with SBRT (experimental group).
Intervention Type
Radiation
Intervention Name(s)
TACE transarterial chemoembolization
Intervention Type
Radiation
Intervention Name(s)
stereotatic body radiotherapy (SBRT)
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
endpoint is OLT
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient capable of giving informed consent Patient diagnosed with hepatocellular carcinoma and listed or recommended to be listed for orthotopic liver transplantation at the participating institution Age > 18 years old Meets clinical criteria for eligibility for TACE to the target lesion per Interventional Radiology Childs' Class A or B7 Eastern Clinical Oncology Group performance status 0 or 1 Exclusion Criteria: Prior radiotherapy to the upper abdomen or radioembolization of the liver Prior TACE to the target lesion, RFA, or liver transplant Active GI bleed within 2 weeks of study enrollment Active GI ulcer disease within 4 weeks of study enrollment Ascites refractory to medical therapy Contraindication to receiving radiotherapy or TACE Complete obstruction of portal venous flow to the segment of liver that includes the target lesion Contraindication to both contrast enhanced MRI and contrast enhanced CT (i.e. unable to undergo follow-up imaging or SBRT treatment planning) Women who are pregnant Participation in another concurrent treatment protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar Ben-Josef, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarita Thomas, MD, PhD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

TACE With or Without SBRT as Bridging Therapy for Pre-transplant HCC Patients

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