Table 2.

Secondary endpoints of the HYPER-LIV01 trial

Tolerance (toxicities are evaluated according to NCI-CTCAE version 4.03 published 14 June 2010).

Post-operative mortality defined as any death within 90 days after surgery or within the hospital stay.

Post-operative morbidity defined as the percentages of grade I/II/II/IV/V complications according to the Clavien-Dindo classification within the 90 days after surgery or within the hospital stay.

Post-hepatectomy liver failure defined according to the “50–50” criteria (Balzan, Ann Surg 2005) or peak bilirubin > 7 mg/dL (Mullen, J Am Coll Surg 2007).

Rate of non-resectability due to insufficient FLR defined as the percentage of patients for whom resection will be not attempted due to insufficient FLR.

Rate of non-resectability due to tumor progression defined as the percentage of patients for whom resection will not be attempted due to tumor progression.

Rate of per-operative difficulties defined as the percentage of patients for whom per-operative difficulties are encountered by the surgeon (especially adhesions and challenging pedicular dissection or any other unscheduled surgical difficulties).

Blood loss, operating time, transfusions. Blood loss (in mL), operating time (in minutes), transfusions (number of packed red blood cells) will be recorded.

R0 resection rate defined as no microscopic tumor residual.

Pre- and post-operative liver volumes: This will be evaluated through CT or MRI acquisitions by calculating whole liver, tumor and FRL volumes at week 2, 3 then every 2 weeks until surgery or week #7, and 4 weeks after surgery (central review).

Overall survival defined as the time from date of randomization to date of death from any cause. Patients alive will be censored at the date of last news.