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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01918683
• Other study ID #: UPCC 16213
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• TACE transarterial chemoembolization

• stereotatic body radiotherapy (SBRT)

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	Loyola University, Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	endpoint is OLT	10 days