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

A Pilot Trial of Transarterial Chemoembolization With or Without Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01918683

Enrollment

Registered

2013-08-08

Start date

2013-07-01

Completion date

2027-12-01

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

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.

Interventions

RADIATIONTACE transarterial chemoembolization

RADIATIONstereotatic body radiotherapy (SBRT)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

two arms

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Progression Free Survival	10 days	endpoint is OLT

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREdgar Ben-Josef, MD

Abramson Cancer Center at Penn Medicine

PRINCIPAL_INVESTIGATORTarita Thomas, MD, PhD

Loyola University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026