Patients affected by advanced or metastatic hepatocellular carcinoma HCC previously treated with no more than one systemic therapeutic regimen MedDRA version: 9.1 Level: LLT Classification code 10055110 Term: Hepatic cancer metastatic
Conditions
Sponsors
MOLMED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 18 years affected by advanced or metastatic HCC previously treated with no more than one systemic therapeutic regimen Histologically confirmed HCC not amenable to curative surgery Child-Pugh scale class A ECOG Performance status 0 1 Patients in progression disease at study entry Adequate baseline bone marrow, hepatic and renal function, defined as follows Neutrophils 1.5 x 109/L and platelets 100 x 109/L; Bilirubin 2 x ULN;Transaminases 3 x ULN;AST and/or ALT 2.5 x ULN in absence of liver metastasis;AST and/or ALT 5 x ULN in presence of liver metastasis Absence of any conditions in which hypervolaemia and its consequences e.g. increased stroke volume, elevated blood pressure or haemodilution could represent a risk for the patient reference appendix Technical data sheet human albumin Normal cardiac function and absence of uncontrolled hypertension written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Decompensated cirrhosis Child-Pugh score 7 Concurrent anticancer therapy Patients may not receive any other investigational agents while on study Clinical signs of CNS involvement Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Antitumour activity defined as progression free survival PFS ;Secondary Objective: Tumor growth control rate TGCR according to WHO criteria Evaluation of Circulating Tumor Cells CTCs and Circulating Endothelial Cells CECs Experimental Imaging Study DCE-MRI Evaluation of adaptative immune response Safety;Primary end point(s): Antitumour activity defined as progression free survival PFS | — |
Countries
Italy
Outcome results
None listed