The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic hepatocellular carcinoma patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic Hepatocellular Carcinoma (HCC) previously treated with no more than one systemic therapeutic regimen, that will be conducted using Simon's two-stage design method.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
Fondazione San Raffaele del Monte Tabor
Milan, Milan, Italy
Istituto Europeo Oncologico
Milan, Milan, Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy
Antitumour activity defined as progression free survival (PFS)
Time frame: during the study
Tumor growth control rate (TGCR) according to WHO criteria
Time frame: during the study
Pharmacokinetics in patients treated with weekly schedule
Time frame: during treatment
Safety
Time frame: during the study
Overall survival (OS)
Time frame: During the treatment and during the follow-up
Experimental imaging study (DCE-MRI)
Time frame: During the treatment
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