Primary liver cancer Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 18 years old or above 2. Present with a Child A or B (Child-Pugh Classification) score 3. A PS equal or less than 2 4. A liver tumor compatible with a Barcelona clinic liver cancer (BCLC) stage B or C HCC which had not been previously submitted to transcatheter arterial chemoembolization (TACE) or any intra-arterial treatment
Exclusion criteria
Exclusion criteria: 1. Performance status scale (PS - Karnofsky performance status scale) of 2 or less 2. No extrahepatic spread of the liver tumor 3. Child-Pugh classification A or B 4. 17 years of age or younger 5. Refusal to sign the Informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Tumor response, assessed via magnetic resonance imaging (MRI) or computed tomography (CT) if patient not able to withstand MRI 2. Progression-free survival, via clinical assessments performed at least every three months over a two year period | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, evaluated during the DEB TACE procedure, immediately after it and during hospital permanence. Assessed via telephone calls and regularly scheduled hospital patient visits over a two year period | — |
Countries
Brazil