The OSPREY Patient Registry has been developed to collect and assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.
The Registry data will provide both complementary and contemporary information to the existing clinical data across various countries and will form part of the post-market clinical follow-up activities for OncoSil™. Therefore, the Registry will be implemented only in countries with regulatory (commercial) approval for the OncoSil™ device.
Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).
Patients who undergo OncoSil™ implantation at an eligible treatment facility.
Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.
Pancreatic target tumour recommended size of <7 cm (longest diameter) and <110 cc volume.
Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
Evidence of distant metastases based on review of baseline CT scan.
More than one primary lesion.
Every patient who is intended to undergo implantation of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, in the commercial (sales) setting will be approached by the Treating Physician to consent to participate in the OSPREY Patient Registry. Patients who choose not to consent to participate in the OSPREY Patient Registry will not be excluded from being treated with the OncoSil™ device. .
Cohort
Prospective
Not listed
Safety and tolerability of Device
The analysis for safety within the real-world setting will be performed. The safety of OncoSil™ is defined by the Adverse Event profile. All safety summaries will be produced for the Intention-To-Treat (ITT) population. Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA). All Adverse Events recorded during the Registry will be listed. Summary tables will be produced for Treatment Emergent Adverse Events (TEAEs). The number and percentage of patients with device-related Adverse Events by system organ class (SOC) and preferred term will be tabulated. Similar summaries will be produced by severity of event (both mild, moderate or severe, CTCAE grade 1-4) and drug and/or device relationship. In addition, summary tables will be produced for serious TEAEs and TEAEs associated with special interest acute/late radiation effects and or withdrawal.
Device Implantation Performance
Safety of the implantation of OncoSil™ within the target tumour will be measured by means of procedure-related Adverse Events. An assessment of the utility of OncoSil™ Implantation will be made and listed appropriately.
Overall Survival
Overall survival (OS) is defined as the time from enrolment to the date of death from any cause. Patients who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the patient was known to be alive. Overall Survival (OS) will be analysed at the interim analysis and once all 500 OncoSil™ implanted patients have been followed to death or to 24-months post the date of the last enrolled/treated patient.
tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1
Target (implanted) tumor response (local and distant)
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