OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.

Launched by ONCOSIL MEDICAL LIMITED · Jul 27, 2020

Keywords

ClinConnect Summary

The OSPREY trial is a study designed to collect information about the OncoSil™ device, which is used to treat patients with locally advanced pancreatic cancer that cannot be surgically removed. This study aims to see how well the device works and how safe it is when combined with a common chemotherapy drug called gemcitabine. The information gathered will help doctors understand the real-world effectiveness and safety of OncoSil™ across different countries where it is approved for use.

To be eligible for the trial, patients must be at least 18 years old and have confirmed locally advanced pancreatic cancer that meets specific size requirements. They also need to be treated at a facility that can provide the OncoSil™ device and must agree to participate by signing an informed consent form. Participants will receive treatment with the OncoSil™ device followed by chemotherapy, and the study will track their progress over time. It’s important to note that not everyone will qualify; certain conditions or medical histories may exclude a patient from participating. If you or a loved one are interested in this study, it could be a way to contribute to understanding a new treatment option for pancreatic cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).
• • 2. Patients who undergo OncoSil™ implantation at an eligible treatment facility.
• • 3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.
• • 4. Pancreatic target tumour recommended size of \<7 cm (longest diameter) and \<110 cc volume.
• • 5. A clinically acceptable ECOG performance status.
• • 6. Patients ≥ 18 years of age at screening.
• • 7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.
• • 8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.
• Exclusion Criteria:
• • 1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
• • 2. Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
• • 3. Evidence of distant metastases based on review of baseline CT scan.
• • 4. More than one primary lesion.
• 5. In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:
• • where previous EUS-FNA was considered technically too difficult to perform;
• • imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;
• • presence (or significant risk) of varices near to the target tumour.
• • 6. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
• • 7. In the setting of recent, clinically significant pancreatitis, implantation is not recommended.
• • 8. Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding.
• • 9. Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components