Registry for patients with unresectable pancreatic cancer treated with OncoSil™

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The OSPREY Patient Registry is designed to collect and evaluate the performance and safety of the OncoSil™ device in patients with unresectable, locally advanced pancreatic cancer. This global, multicentre, observational registry will gather data from patients undergoing OncoSil™ implantation in combination with gemcitabine-based chemotherapy. Data will be collected over a 12-month period following patient enrollment, with a total follow-up extending to 24 months post the last patient implanted. The registry aims to provide real-world evidence to complement existing clinical data and support post-market clinical follow-up activities for the OncoSil™ device.

Why it matters

Who can join: the full rules

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

Where it's running

• Complejo Hospitalario Universitario Insular Materno-Infantil
  Las Palmas de Gran Canaria, Spain Recruiting
• Hospital Universitario Ramón y Cajal
  Madrid, Spain Recruiting
• Hospital Universitario de Fuenlabrada
  Madrid, Spain Recruiting
• Clinica Universidad De Navarra
  Pamplona, Spain Recruiting
• Hospital Clinico Universitario De Valladolid
  Valladolid, Spain Recruiting
• Hospital Universitario Doce De Octobre
  Madrid, Spain Not yet recruiting

Study contacts

• Principal investigator: Paul J Ross, MRCP, MBBS — Guy's and St Thomas' NHS Foundation Trust, London, UK
• Study coordinator: Tom Maher
• Email: tom.maher@oncosil.com
• Phone: +44 750 4658585

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.