Baseline | Liver preparation | After liver preparation | Surgeryb | Post-op follow-up | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Treatment | During hospitalization | Week 1 | Week 3 | Every 2 weeks or week 7 | During hospitalization | Week 4 | Day 90 | |||
D-30 – D0 | D-8 – D0 | D0 | Each daya | D0 + 7 days (+/− 1 day) | D0 + 21 days (+/− 1 day) | Each dayc | Surgery + 28 days (+/− 1 day) | Surgery + 90 days (+/− 1 day) | ||
Inclusion/exclusion criteria | X | X | ||||||||
Written consent | X | |||||||||
Demographics | X | |||||||||
Medical history | X | |||||||||
Clinical evaluation | X | X | X | X | X | X | X | X | ||
ECOG performance status | X | X | X | X | X | X | X | X | ||
Prior/concomitant medications | X | X | X | X | X | X | X | X | ||
Biological evaluation | X | Xf | X | X | X | Xg | X | X | ||
Serum pregnancy | X | |||||||||
Biological collection (translational research) | Xd | Xd | X | Xe | ||||||
Liver biopsy (translational research) | X | Xh | ||||||||
99 m-Tc mebrofenin scintigraphy (translational research) | X | X | X | X | X | |||||
Spiral CT/MRI of abdomen | X | X | X | X | X | X | ||||
Randomization | X | |||||||||
Liver venous deprivation/portal vein embolization | X | |||||||||
Adverse events/Serious adverse events | X | X | X | X | X | X | X |