Stereotactic Body Radiation Therapy as a Bridge-to-transplant for Patients With Hepatocellular Carcinoma and Advanced Cirrhosis

PRIMARY OBJECTIVES:

I. Assess the use of stereotactic body radiation therapy (SBRT) in hepatocellular carcinoma
(HCC) patients with advanced liver cirrhosis as a feasible approach to providing localized
disease control that adequately suffices liver transplant eligibility criteria.

SECONDARY OBJECTIVES:

I. Assess preliminary efficacy and toxicity in HCC patients with advanced cirrhosis following
liver SBRT.

EXPLORATORY OBJECTIVES:

I. Assess qualify of life in HCC patients with advanced cirrhosis following liver SBRT.

OUTLINE:

Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up at 6 weeks, then every 3 months
for up to 2 years.

Inclusion Criteria:

- Ability to understand and the willingness to sign a written informed consent document

- At time of enrollment, patient with clinically-confirmed non-metastatic HCC with >=
700 cc uninvolved tumor volume

- Must be listed or recommended to be listed for orthotopic liver transplantation at the
participating institution

- Have a Child-Pugh (CP) score >= B8

- Eastern Clinical Oncology Group (ECOG) performance status =< 2, or Karnofsky
Performance Scale > 60

- Must have a life expectancy > 12 weeks

- Except for prior radiotherapy or radioembolization, other prior therapies to
previously treated lesions, are permitted

- Female participants of childbearing potential must have a negative urine or serum
pregnancy test within 72 hours prior to receiving the first dose of SBRT. If the urine
test is positive or cannot be confirmed as negative, a serum pregnancy test will be
required

- Female participants of childbearing potential agree to use adequate methods of
contraception starting with the first dose of study therapy through 60 days after the
last dose of study therapy. Participants of childbearing potential are those who have
not been surgically sterilized or have not been free from menses for > 1 year without
an alternative medical cause

- Note: Abstinence is acceptable if this is the preferred contraception for the
participant

- Male participants must agree to use an adequate method of contraception starting with
the first dose of study therapy through 60 days after the last dose of study therapy

- Note: Abstinence is acceptable if this is the preferred contraception for the
participant

- No other prior invasive malignancy is allowed except for the following: adequately
treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer. Stage
I or II invasive cancer treated with a curative intent without evidence of disease
recurrence for at least five years

Exclusion Criteria:

- Participants have any one of the following liver tumor characteristics:

- Have > 5 liver tumors, or

- Maximal diameter > 5 cm

- Complete obstruction of portal venous flow to the segment of liver that includes the
target lesion

- Prior radiotherapy to the upper abdomen or radioembolization of the liver, or prior
thermal ablation to the target lesion

- For fiducial marker placement:

- Have a gold allergy

- Any coagulopathy preventing safe fiducial placement

- Contraindication to both contrast enhanced magnetic resonance imaging (MRI) and
contrast enhanced computed tomography (CT) (i.e. unable to undergo follow-up imaging
or SBRT treatment planning)

- Participation in another concurrent treatment protocol

- Participant is pregnant or breastfeeding, or expecting to conceive or father children
within the projected duration of the trial, starting with the screening visit through
120 days after the last dose of trial treatment

- Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic
gastrointestinal conditions associated with diarrhea, or psychiatric illness/social
situations that would limit compliance with study requirement, substantially increase
risk of incurring adverse events (AEs) or compromise the ability of the patient to
give written informed consent