Last updated: April 29, 2024
Sponsor: OncoSil Medical Limited
Overall Status: Active - Recruiting
Phase
N/A
Condition
Neoplasms
Stomach Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
NCT04493632
OSPREY01
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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) forthe OSPREY Patient Registry.
- Pancreatic target tumour recommended size of <7 cm (longest diameter) and <110 ccvolume.
- A clinically acceptable ECOG performance status.
- Patients ≥ 18 years of age at screening.
- To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to theapproved prescribing schedule) post Registry enrolment.
- Adequate biochemical tests, coagulation profile, haematological, renal, and hepaticfunction as determined by the Treating Physician.
Exclusion
Exclusion Criteria:
- Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREYPatient 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.
- In the opinion of the Treating Physician, EUS-directed implantation posing unduepatient risk. This includes:
- where previous EUS-FNA was considered technically too difficult to perform;
- imaging demonstrates multiple collateral vessels surrounding or adjacent to thetarget tumour within the pancreas;
- presence (or significant risk) of varices near to the target tumour.
- Evidence of radiographic invasion into stomach or duodenum (if not certain,confirmation must be obtained prior to enrolment).
- In the setting of recent, clinically significant pancreatitis, implantation is notrecommended.
- Pregnant or intending to commence a pregnancy within 12-months of the intended date ofimplantation or breastfeeding.
- Patients who have a known history of hypersensitivity to silicon or phosphorous, orany of the OncoSil™ components
Study Design
Total Participants: 500
Study Start date:
April 12, 2022
Estimated Completion Date:
October 01, 2027
Study Description
Connect with a study center
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas De Gran Canaria,
SpainActive - Recruiting
Hospital Universitario Doce De Octobre
Madrid,
SpainSite Not Available
Hospital Universitario La Paz
Madrid,
SpainSite Not Available
Hospital Universitario Ramón y Cajal
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario de Fuenlabrada
Madrid, 28942
SpainActive - Recruiting
Clinica Universidad De Navarra
Pamplona,
SpainActive - Recruiting
Hospital Clinico Universitario De Valladolid
Valladolid,
SpainActive - Recruiting
Hammersmith Hospital
London,
United KingdomSite Not Available
The London Clinic
London,
United KingdomSite Not Available
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