Hepatocellular carcinoma
Conditions
Interventions
?Transarterial Chemoembolization: direct intravascular administration of chemotherapy and embolization material under general anesthesia/sedation.
?SABR: Stereotactic ablative radiotherapy (outpatien
and 3 years for survival only
Sponsors
Stanford Comprehensive Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: ?Confirmed hepatocellular carcinoma (HCC) by one of the following: -Histopathology -One radiographic technique that confirms a lesion > 1cm 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 ?ECOG (Eastern Clinical Oncology Group) performance status 0, 1 or 2 ?Patients with liver disease classified as Child Pugh class A or B, with score < 9 ?Life expectancy > 6 months ?Age > 18 years old ?Acceptable organ function as defined below (within 2 weeks of date of eligibility): -Albumin > 2.4 g/dL -Total bilirubin < 3 mg/dL -INR < 1.5 -Creatinine < 2.0 mg/dL ?Ability of the research subject or authorized legal representative to understand and have the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: ?Prior radiotherapy to the upper abdomen ?Prior radioembolization to the liver ?Prior 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from local progression (FFLP) at 6 and 12 months as defined in Section 8. (Sample size is powered for 12-month endpoint.) | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Progression-free survival (PFS). ?Overall survival (OS). ?Serum AFP levels. ?FFLP at 18 months. | — |
Countries
Japan,North America
Outcome results
None listed