A Study to Evaluate Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant

Overview

About this study

The purpose of this study is to 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult subjects of all ages, both sexes and all races will be included in this study.
  • Subjects must be 18 years of age or older.
  • Subjects with HCC are eligible for this trial. HCC is defined as having at least one of the following:
    • Biopsy proven HCC or:
      • A discrete hepatic tumor(s) as defined by the Barcelona (29) criteria for cirrhotic subjects;
      • ≥ 2cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI.
  • Subjects are liver transplant candidates (actively awaiting organ transplant per transplant services in documentation), or, potential liver transplant candidates (at the discretion of the liver team and/or Principal Investigator) advised by liver transplant services as needing local treatment prior to liver transplant evaluation.
  • Subjects must be within UCSF criteria (one solitary tumor smaller than 6.5 cm, or patients having 3 or fewer nodules, with the largest lesion being smaller than 4.5 cm or having a total tumor diameter less than 8.5 cm without vascular invasion) and eligible for potential liver transplant.
  • Subjects must be eligible per standard of care for either TACE or SBRT procedures.
  • Subjects must have a life expectancy of at least 12 weeks.
  • Subjects must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of record .
  • Subjects must have a Child-Turcotte-Pugh (CTP) score ≤ 8.
  • Patients must have adequate organ function within 2 weeks of enrollment.
    • Bone marrow:
      • Platelets ≥ 30,000/mm^3.
    • Renal:
      • BUN ≤ 40 mg/dl; creatinine ≤ 2.0 mg/dl .
    • Hepatic:
      • INR ≤ 1.5 or correctable by Vitamin K, unless anti-coagulated for another medical reason.
    • Bilirubin < 3.0 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract; e.g., primary sclerosing cholangitis).
  • Patients uninvolved liver volume will be estimated and must be > 700ml.
  • Patients must have a Zubrod performance status of ≤ 2.
  • Patients who are sexually active must agree to the use of contraception throughout the duration of the study.

Exclusion Criteria:

  • Bone marrow: Platelets ≥ 30,000/mm^3
  • Renal: BUN ≤ 40 mg/dl; creatinine ≤  mg/dl
  • Hepatic: INR ≤ 1.5 or correctable by Vitamin K, unless anti-coagulated for another medical reason.
  • Bilirubin < 3.0 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract; e.g., primary sclerosing cholangitis).
  • Patients’ uninvolved liver volume will be estimated and must be > 700ml.
  • Patients must have a Zubrod performance status of ≤ 2.
  • Patients who are sexually active must agree to the use of contraception throughout the duration of the study.

Exclusion Criteria:

  • Subjects in a “special category” as designated by FDA and the Canadian Institutes of Health or Canadian Panel on Research Ethics including subjects younger than 18, pregnant women, and prisoners.
  • Refractory ascites that requires paracentesis for management.
  • Known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.
  • History of prior radiation to the liver.
  • Evidence of metastatic disease.
  • Presence of a Trans-jugular intra-hepatic porto-systemic shunt (TIPS).
  • Untreated varices at high risk of bleeding.
  • Bile duct occlusion or a prior diagnosis of an incompetent papilla.
  • Acute infection.
  • Uncorrectable bleeding disorder.
  • Leukopenia, ANC < 1000/ul.
  • Hepatic encephalopathy.
  • Portal vein thrombosis.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Christopher Hallemeier, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available