Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT03172559
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03172559
Study Brief:
Protocol Section:
NCT03172559