Registry for patients with unresectable pancreatic cancer treated with OncoSil™

OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)

This study is testing how well the OncoSil™ device works and its safety for people with advanced pancreatic cancer who are also receiving chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: OncoSil Medical Limited (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 9 sites (Las Palmas de Gran Canaria and 8 other locations)
• Trial ID: NCT04493632 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this registry are adults aged 18 and older with confirmed unresectable locally advanced pancreatic cancer who are undergoing treatment with the OncoSil™ device.

Not a fit: Patients who are not undergoing treatment with the OncoSil™ device or those who have not provided informed consent will not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could enhance understanding of the OncoSil™ device's effectiveness and safety, potentially improving treatment outcomes for patients with pancreatic cancer.

How similar studies have performed: While this registry approach is not novel, it builds on existing post-market surveillance practices, and similar studies have shown success in gathering valuable real-world data.

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

Where this trial is running

Las Palmas de Gran Canaria and 8 other locations

• 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)
• Hospital Universitario Doce De Octobre — Madrid, Spain (Not_yet_recruiting)
• Hospital Universitario La Paz — Madrid, Spain (Not_yet_recruiting)
• Clinica Universidad De Navarra — Pamplona, Spain (Recruiting)
• Hospital Clinico Universitario De Valladolid — Valladolid, Spain (Recruiting)
• Hammersmith Hospital — London, United Kingdom (Not_yet_recruiting)
• The London Clinic — London, United Kingdom (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

Conditions Pancreatic Neoplasm; Digestive System Neoplasm; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasm; Digestive System Disease; Pancreatic Diseases; Endocrine System Diseases