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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: TACE transarterial chemoembolization
* Radiation: stereotatic body radiotherapy (SBRT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A -Tace alone<br>A - TACE alone (control group, current practice and treatment) | Radiation: TACE transarterial chemoembolization<br> <br> |
| Experimental: B - Tace combined with SBRT<br>B- TACE combined with SBRT (experimental group). | Radiation: TACE transarterial chemoembolization<br> <br> Radiation: stereotatic body radiotherapy (SBRT)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | endpoint is OLT | 10 days |