Status:
ACTIVE_NOT_RECRUITING
TACE With or Without SBRT as Bridging Therapy for Pre-transplant HCC Patients
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
Loyola University
Oregon Health and Science University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 prospecti...
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 he...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01918683
Start Date
July 1 2013
End Date
December 1 2027
Last Update
January 28 2025
Active Locations (3)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153
2
Oregon Health & Science University
Portland, Oregon, United States, 97239
3
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104