NGR008: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma (HCC) Previously Treated With no More Than One Systemic Therapeutic Regimen
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 CT documented
- Adequate baseline bone marrow, hepatic and renal function, defined as follows:
- Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L
- Bilirubin < 2 x ULN
- Transaminases < 3 x ULN
- 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
- Patients must give written informed consent
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. Patients - both males and females - with reproductive
potential (i.e. menopausal for less than 1-year and not surgically sterilized) must
practice effective contraceptive measures throughout the study. Women of childbearing
potential must provide a negative pregnancy test (serum or urine) within 14 days
prior to registration