Criticare Saúde

1. HiQUALITY Study:
HepaSphere / QuadraSphere
in Liver Cancer Treatment

2. STUDY DESIGN
 Phase 3, multicenter, randomized, prospective study
 25 sites in US and Europe; 520 patients
 HepaSphere/QuadraSphere to deliver doxorubicin
compared to cTACE with doxorubicin, lipiodol & nsPVA
 Principal Investigator: Michael Soulen MD
 Central Imaging: Riccardo Lencioni MD
 Data Safety Monitoring: Josep Llovet MD

3. HiQUALITY Study: Endpoints
 PRIMARY
– Overall survival
 SECONDARY
– Objective tumor response by mRECIST criteria
– Overall adverse event rates
– Doxorubicin related adverse events
– Objective tumor response in the treated area
 TERTIARY
– Time to untreatable progression

4. HiQUALITY Study: MAIN Inclusion Criteria
 Patients with HCC not suitable for treatment by
resection or percutaneous ablation at time of study
entry
 Life expectancy at least 6 months
 Absence of occlusive thrombus to the main portal trunk
 Patient must meet at least one of the following:
 Child-Pugh B7
 Recurrent HCC
 Performance status ECOG 1

5. HiQUALITY Study: MAIN Exclusion Criteria
 Current or previous treatment by chemo- or radiation
therapy or sorafenib, or previous embolization for HCC
 ECOG score ≥ 2, Child-Pugh score ≥ 8
 > 50% tumor involvement of liver or diffuse cancer
 Extrahepatic spread
 Encephalopathy not medically controlled or clinically
relevant ascites
 Contraindications for doxorubicin, embolization or MRI