Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant
- 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 be 18 years of age or older. Adult subjects of all ages, both sexes and all races will be included in this study.
- 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/mm3
- 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.
- Subjects in a "special category" designated by the Public Health Service, 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).
For patients with hepatocellular carcinoma (HCC) who are waiting for a liver transplant, local treatment of their disease has become the standard of care in an effort to decrease dropout rates and as a means of reducing tumor recurrence after transplantation. For patients undergoing local regional therapy as a bridge to transplantation, trans-arterial chemoembolization (TACE) is the most commonly utilized treatment. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. A newer strategy for the treatment of HCC is stereotactic body radiation therapy (SBRT). This study will compare SBRT to TACE as a bridging strategy for patients with HCC undergoing liver transplantation.
Trial Phase Phase III
Trial Type Treatment
Lahey Hospital and Medical Center
- Primary ID 20193013
- Secondary IDs NCI-2020-04722
- Clinicaltrials.gov ID NCT03960008