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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT02762266
Eligibility Criteria:
Inclusion Criteria:
* Confirmed hepatocellular carcinoma (HCC) by one of the following:
* Histopathology
* One radiographic technique that confirms a lesion \>= 1 cm with arterial hypervascularization with washout on delayed phase
* Radiographic evidence of persistent, progressive, or recurrent disease in an area previously treated with TACE and determined from 3 months after initial TACE; this evaluation should be within 6 weeks of date of study eligibility
* Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension; multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 10 cm as long as the dose constraints to normal tissue can be met
* Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2
* Patients with liver disease classified as Child Pugh class A or B, with score =\< 9 ((within 4 weeks of treatment)
* Life expectancy \>= 6 months
* Ability of the research subject or authorized legal representative to understand and have the willingness to sign a written informed consent document
Exclusion Criteria:
* Prior radiotherapy to the upper abdomen
* Prior radioembolization to the liver
* Prior radiofrequency ablation (RFA) to index lesion
* Liver transplant
* Active gastrointestinal bleed within 2 weeks of study enrollment
* Ascites refractory to medical therapy (mild to moderate ascites is allowed)
* Women who are pregnant or breastfeeding
* Administration of chemotherapy within the last 1 month
* Extrahepatic metastases
* Participation in another concurrent treatment protocol
* Prior history of malignancy other than HCC, dermatologic basal cell or squamous cell carcinoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02762266
Study Brief:
Protocol Section:
NCT02762266