SBRT vs TACE as Bridge to Transplant for Liver Cancer

(SBRTvsTACE Trial)

Recruiting at4 trial locations

Overseen by Corrine Zarwan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Lahey Clinic

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to liver transplantation in subjects with HCC.

Research Team

Corrine Zarwan, MD

Principal Investigator

Lahey Hospital & Medical Center

Eligibility Criteria

This trial is for adults with Hepatocellular Carcinoma (HCC) who are candidates for liver transplantation. They must meet specific criteria including having a tumor within certain size limits, good organ function, and no history of prior radiation to the liver or evidence of metastatic disease. Pregnant women, individuals under 18, and those with severe allergies to contrast agents or refractory ascites are excluded.

Inclusion Criteria

I am 18 years old or older.

Subjects must have a life expectancy of at least 12 weeks.

I have been diagnosed with hepatocellular carcinoma (HCC).

Exclusion Criteria

Presence of a Trans-jugular intra-hepatic porto-systemic shunt (TIPS).

I am allergic to certain IV dyes even after taking prednisone.

I need a procedure to remove excess belly fluid.

Treatment Details

Interventions

• Doxorubin (Anti-tumor antibiotic)
• Stereotactic Body Radiation Therapy (SBRT) (Radiation)
• Trans-Arterial Chemoembolization (TACE) (Procedure)

Trial Overview The study compares Stereotactic Body Radiation Therapy (SBRT) and Trans-Arterial Chemoembolization (TACE), using Doxorubicin as a bridge treatment before liver transplant in HCC patients. It aims to determine if SBRT leads to longer intervals without needing retreatment compared to TACE.

Participant Groups

Group I: Trans-Arterial Chemoembolization (TACE) Experimental Treatment 2 Interventions

Procedure/Surgery - Chemoembolization Drug: Doxorubin

Group II: Stereotactic Body Radiation Therapy (SBRT) Experimental Treatment 1 Intervention

Radiation Therapy

Stereotactic Body Radiation Therapy (SBRT) is already approved in Canada, Japan for the following indications:

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Japan as Stereotactic Body Radiation Therapy for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Who Is Running the Clinical Trial?

Lahey Clinic

Lead Sponsor

Trials

74

Recruited

245,000+

Dr. Susan Moffatt-Bruce

Lahey Clinic

Chief Executive Officer since 2023

PhD in Transplant Immunology from University of Cambridge, MD from Dalhousie University, MBA from Fisher College of Business at The Ohio State University

Dr. Tim Liesching

Lahey Clinic

Chief Medical Officer since 2022

MD

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Merit Medical Systems, Inc.

Industry Sponsor

Trials

35

Recruited

3,500+