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

NCT01918683 | Active Not Recruiting DMC

• 1 other identifier: UPCC 16213
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  endpoint is OLT

  10 days

Study Arms (2)

A -Tace alone

OTHER

A - TACE alone (control group, current practice and treatment)

Radiation: TACE transarterial chemoembolization

B - Tace combined with SBRT

EXPERIMENTAL

B- TACE combined with SBRT (experimental group).

Radiation: TACE transarterial chemoembolization; Radiation: stereotatic body radiotherapy (SBRT)

Interventions

TACE transarterial chemoembolization RADIATION

A -Tace alone; B - Tace combined with SBRT

stereotatic body radiotherapy (SBRT) RADIATION

B - Tace combined with SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Loyola University: collaborator
• Oregon Health and Science University: collaborator

Study Sites (3)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Edgar Ben-Josef, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

• Tarita Thomas, MD, PhD

  Loyola University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two arms

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 8, 2013
• Study Start: July 1, 2013
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (3)