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

Not Applicable

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: TACE transarterial chemoembolization; Radiation: stereotatic body radiotherapy (SBRT)

• Registration Number: NCT01918683
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-07
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A -Tace alone	TACE transarterial chemoembolization	A - TACE alone (control group, current practice and treatment)
B - Tace combined with SBRT	TACE transarterial chemoembolization	B- TACE combined with SBRT (experimental group).
B - Tace combined with SBRT	stereotatic body radiotherapy (SBRT)	B- TACE combined with SBRT (experimental group).

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	10 days	endpoint is OLT

Trial Locations

Locations (3)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States