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 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT01899261
Eligibility Criteria:
Inclusion Criteria:
* Life expectancy \> 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* HCC diagnosed by either of the following approaches:
* Histologic confirmation of HCC on biopsy
* Evidence of vascular enhancement of suspected lesion on at least two imaging techniques
* Evidence of vascular enhancement on a single technique if the alpha-fetoprotein (AFP) is \> 200 ng/mL in the setting of cirrhosis or chronic hepatitis B/C
* HCC must be deemed unresectable by an experienced surgeon or patient must be medically inoperable or extra-hepatic metastases must be present (making resection an inappropriate treatment option) or patient must have declined the option of surgery after consultation with a surgeon
* Barcelona Clinic Liver Cancer score of B or C required (i.e., intermediate or advanced stage HCC)
* Prior liver resection or ablative therapy is permitted
* Prior transarterial chemoembolization (TACE) is permitted
* Patients must have recovered from the effects of previous therapy
* Maximal tumor size of 15 cm and \> 700 cc of uninvolved liver
* Hemoglobin \> 9.0 g/L
* Absolute neutrophil count \>= 1.0 bil/L
* Platelets \>= 70,000 bil/L
* Total bilirubin \< 2 mg/dL
* International normalized ratio (INR) =\< 1.5 or correctable with vitamin K (higher INR acceptable if patient is on Coumadin)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 6 times upper range of normal
Exclusion Criteria:
* Active hepatitis or encephalopathy related to liver failure
* Prior radiation therapy to the upper abdomen or thorax
* Lesions within 1 cm from the stomach
* Prior uncontrolled, life threatening malignancy within the previous 6 months
* Pregnancy is not permitted; women of child-bearing age must undergo pregnancy testing prior to enrollment
* Previous gastric, duodenal or variceal bleed within the past 2 months
* Thrombolytic therapy within 4 weeks or commencement of anticoagulant use within the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01899261
Study Brief:
Protocol Section:
NCT01899261