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ORR is defined as the proportion of patients achieving either complete or partial tumor response during the study, as assessed by blinded central image review according to localized mRECIST
The number and percent of patients with a confirmed response
The number and percent of patients with a confirmed response
The number and percent of patients with a DoR ≥ 6 months. DoR is measured from time of initial response until radiological progression. Radiological progression is determined by blinded central image review according to localized mRECIST and mRECIST.
TTP defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to progression as per mRECIST
PFS defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to the date of radiological progression or death from any cause. Radiological progression is determined by blinded central image review according to mRECIST
hPFS defined as the time from treatment with QuiremSpheresTM Holmium-166 Microspheres to the date of radiological progression in the liver or death from any cause. Radiological progression is determined by blinded central image review according to mRECIST
The number and percent of patients receiving a liver transplant
The number and percent of patients undergoing a liver resection
The median overall survival time
Adverse events classified by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. (including clinical and laboratory toxicity)
ALBI score
MELD score
Child Pugh score
Correlation between scout and treatment for extrahepatic dose deposition, including lung shunt and digestive shunting of QuiremSpheresTM Holmium-166 Microspheres.
Correlation between treatment-based absorbed dose (into the tumor and healthy liver) and clinical outcomes in terms of toxicity and efficacy (i.e. radiological response).
Correlation between scout-based simulated absorbed dose (into the tumor and healthy liver) and the treatment based absorbed dose (into the tumor and healthy liver).
Patient reported outcome using EQ-5D-5L questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.