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

Running, not enrolling · Not applicable

Conditions studied: Hepatocellular Carcinoma

In brief

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

Key facts

Study ID

NCT01918683

Run by

Abramson Cancer Center at Penn Medicine

People needed

40

Starts

2013-07-01

Expected to finish

2027-12-01

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loyola University Medical Center — Maywood, Illinois, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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