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

Last updated: January 28, 2026
Sponsor: Abramson Cancer Center at Penn Medicine
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cancer

Carcinoma

Liver Cancer

Treatment

stereotatic body radiotherapy (SBRT)

TACE transarterial chemoembolization

Clinical Study ID

NCT01918683
UPCC 16213
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient capable of giving informed consent

  • Patient diagnosed with hepatocellular carcinoma and listed or recommended to belisted for orthotopic liver transplantation at the participating institution

  • Age > 18 years old

  • Meets clinical criteria for eligibility for TACE to the target lesion perInterventional Radiology

  • Childs' Class A or B7

  • Eastern Clinical Oncology Group performance status 0 or 1

Exclusion

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 thetarget lesion

  • Contraindication to both contrast enhanced MRI and contrast enhanced CT (i.e. unableto undergo follow-up imaging or SBRT treatment planning)

  • Women who are pregnant

  • Participation in another concurrent treatment protocol

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: stereotatic body radiotherapy (SBRT)
Phase:
Study Start date:
July 01, 2013
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood 4901514, Illinois 4896861 60153
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

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