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Active, not recruiting

NCT Number: NCT01918683

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

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Medical Center, Maywood, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TACE transarterial chemoembolization

Radiation

stereotatic body radiotherapy (SBRT)

Radiation

Primary outcomes

  1. Progression Free Survival

    Time frame: 10 days

    endpoint is OLT

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Loyola University
  • Oregon Health and Science University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2026
Study completion
2027
First posted
Aug 8, 2013
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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