This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres
This is a global, multi-center, prospective, observational cohort study (registry) to assess real-world outcomes in patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy who have been prescribed SIRT with SIR-Spheres per medical decision. The study will be conducted through the involvement of approximately 845 patients from up to 44 sites in an estimated 10 countries.
Study Type
OBSERVATIONAL
Enrollment
845
Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.
Hôpital Beaujon
Clichy, Cedex, France
RECRUITINGHopital Henri Mondor
Créteil, Paris, France
NOT_YET_RECRUITINGHospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud
Progression-free survival (PFS)
Time frame: 24months from LPI
Liver PFS (LPFS)
Time frame: 24months from LPI
Overall survival (OS)
Time frame: 24months from LPI
Objective response rate (ORR) and liver response rate (LRR)
Time frame: 24months from LPI
Duration of response (DoR)
Time frame: 24months from LPI
Change scores from baseline to follow-up timepoints of the EQ-5D-5L
The (EurolQol) EQ-5D-5L is comprised of five questions on mobility, self-care, pain, usual activities, and psychological status with 5 level answers, 5 being extreme and 1 minimum.
Time frame: 24months from LPI
Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30)
The 30 EORTC QLQ-C30 items constitute consist of 9 domains: physical function, role function, cognitive function, emotional function, social function, fatigue, pain, nausea and vomiting, and global health status. Items are answered on a scale of 1 to 4 or 1 to 7.
Time frame: 24months from LPI
Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Hepatocellular Carcinoma module (EORTC QLQ-HCC18)
The EORTC QLQ-HCC18 instrument consists of 6 symptom scales and 2 single items: that measures fatigue, body image, jaundice, nutrition, pain, fever, sexual interest and abdominal swelling. Scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much').
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Pierre-Bénite, Rhône, France
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain
NOT_YET_RECRUITINGHospital General Universitario Gregorio Marañon
Madrid, Spain
NOT_YET_RECRUITINGHospital Clinico Universitario de Valencia
Valencia, Spain
NOT_YET_RECRUITINGThe Christie Hospital
Manchester, Lancashire, United Kingdom
NOT_YET_RECRUITINGKings College Hospital
London, United Kingdom
NOT_YET_RECRUITINGHammersmith Hospital
London, United Kingdom
NOT_YET_RECRUITINGTime frame: 24months from LPI
SAEs/SADE's rates
Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates
Time frame: 24months from LPI
Subsequent hepatic procedures summarized at follow-up timepoints
Subsequent hepatic procedures like number and type of retreatment and surgery are summarized at follow-up timepoints
Time frame: 24months from LPI
Healthcare Resource Utilization summarized at follow-up timepoints
The total HCRU of each time point specified in the protocol will be summarized using descriptive statistics.
Time frame: 24months from LPI