Radiotherapy Versus no Intervention in Adult Patients With Hepatocellular Carcinoma Not Eligible for Transarterial Chemoembolization or Ablation Prior to Liver Transplant (RADBRI) (RADBRI)
Hepatocellular Carcinoma

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Stereotactic body radiotherapy, SBRT, Radiotherapy, Bridging therapy, Transplant
Eligibility Criteria
Inclusion Criteria:
- 18-75 years old
- Patient has been included in the waiting list to receive a Liver Transplant (LT)
- Radiological confirmation of Hepatocellular carcinoma (HCC) according to American Association for the Study of Liver Diseases (AASLD) guidelines
- Tumor burden at randomization within a total tumor volume (TTV) ≤115 cm3 and serum alpha-fetoprotein (AFP) ≤400 ng/mL
- Patient not eligible to bridging therapy with Transarterial Chemoembolization (TACE) and/or ablation.
- Child-Pugh score ≤B9
- Calculated Model of End Stage Liver disease (MELD) score ≤20
- Eligible to Stereotactic body radiotherapy (SBRT): >40% of liver parenchyma can be spared from radiation and all tumors can be targeted
- No previous treatment of the tumor
- Absence of extra-hepatic disease or vascular invasion on imaging
- Able and willing to provide consent
Exclusion Criteria:
- Patient with HCC not candidate to receive a LT
- Patient is eligible to TACE or ablation as a bridge to LT
- Patient is not eligible to SBRT
- Previous bridging therapies
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Stereotactic body radiotherapy
No intervention
Stereotactic body radiotherapy (SBRT) treatment will be individualized with the dose based on baseline liver function, effective liver volume irradiated and proximity to other normal tissues. The recommended dose will be 30 gray (Gy) in 5 fractions. The treatment will be administered in 5 alternative days. Patients will come every other day to the hospital to be treated and will not need to be admitted. Patients will not receive further SBRT on the treated tumor.
Follow-up will be carried out every 3 months and a computed tomography (CT) scan of the chest and abdomen or an magnetic resonance imaging (MRI), and blood work with liver function test and alpha-fetoprotein (AFP) value will be done until the patient is transplanted or drops-out of the waiting list.