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:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01668134
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18
* Karnofsky Performance Status of ≥ 60
* Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion enhances typically on MRI and the patient is evaluated by liver transplant surgery team and thought to have HCC.)
* 4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by EASL Criteria.
* Local surgical resection is not possible due to tumor or patient factors
* Limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease.
* Prior TACE allowed if stopped/completed at least 2 weeks prior to enrollment
* Prior chemotherapy except Sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment
* Prior Sorafenib allowed if stopped/completed at least seven days prior to enrollment.
* Able to provide signed informed consent
Exclusion Criteria:
* Childs-Pugh score 9 or more
* ALT or AST ≥ 6 x upper limit of normal
* Prior history of abdominal irradiation
* Women who are pregnant or nursing
* Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy.
* Scheduled to undergo Sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy.
* Undergone prior radiation therapy to the abdomen.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01668134
Study Brief:
Protocol Section:
NCT01668134