TACE + SBRT for Liver Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Tarita Thomas, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abramson Cancer Center of the University of Pennsylvania

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Research Team

Edgar Ben-Josef, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Tarita Thomas, MD, PhD

Principal Investigator

Loyola University

Eligibility Criteria

This trial is for adults over 18 with hepatocellular carcinoma who are on or recommended for a liver transplant list. They should be able to undergo TACE, have Childs' Class A or B7 liver function, and an ECOG performance status of 0 or 1. Pregnant women, those in other treatment studies, with certain medical conditions like active GI ulcers or bleeds, prior upper abdomen radiotherapy or liver treatments are excluded.

Inclusion Criteria

I am older than 18 years.

I am eligible for a specific liver cancer treatment as per my radiologist.

I am able to understand and agree to the study's procedures and risks.

Exclusion Criteria

I have had TACE, RFA, or a liver transplant for my liver lesion.

I cannot have MRI or CT scans with contrast due to health reasons.

Blood flow in the vein to part of my liver with the cancer is completely blocked.

Treatment Details

Interventions

• Stereotatic Body Radiotherapy (SBRT) (Radiation Therapy)
• Transarterial Chemoembolization (TACE) (Chemotherapy)

Trial Overview The study is testing if combining two treatments—TACE and SBRT—is effective as a temporary solution (bridging therapy) for patients with liver cancer waiting for a transplant. It's the first study of its kind and aims to enroll 40 patients into each treatment group.

Participant Groups

Group I: B - Tace combined with SBRT Experimental Treatment 2 Interventions

B- TACE combined with SBRT (experimental group).

Group II: A -Tace alone Experimental Treatment 1 Intervention

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

Transarterial Chemoembolization (TACE) is already approved in China, Japan for the following indications:

Approved in China as TACE for:

• Hepatocellular carcinoma (HCC)
• Liver cancer

Approved in Japan as TACE for:

• Hepatocellular carcinoma (HCC)
• Liver cancer

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Dr. Robert H. Vonderheide

Abramson Cancer Center of the University of Pennsylvania

Chief Executive Officer since 2017

DPhil in Immunology from Oxford University, MD from Harvard Medical School

Dr. Lawrence N. Shulman

Abramson Cancer Center of the University of Pennsylvania

Chief Medical Officer since 2017

MD from Harvard Medical School

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Dr. Robert H. Vonderheide

Abramson Cancer Center at Penn Medicine

Chief Executive Officer since 2017

MD from Harvard Medical School

Dr. Bonnie Ky

Abramson Cancer Center at Penn Medicine

Chief Medical Officer

MD, MSCE from University of Pennsylvania

Loyola University

Collaborator

Trials

161

Recruited

31,400+

Jerome D. Jabbour

Loyola University

Chief Executive Officer since 2018

B.A. in Psychology from Loyola University in Baltimore, Maryland

Dr. Chris Cabell

Loyola University

Chief Medical Officer since 2024

Medical Degree and Masters in Health Sciences from Duke University

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

John Hunter

Oregon Health and Science University

Chief Medical Officer since 2024

MD, specific details unavailable

Ann Madden Rice

Oregon Health and Science University

Chief Executive Officer

FACHE certification, extensive leadership experience in academic health centers