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
