Safety and feasibility of CT-guided percutaneous radionuclide therapy with the OncoSil* device in patients with non-progressive locally advanced pancreatic cancer (PANCOSIL): an open-label, single-arm phase 1-2 feasibility study

Safety and feasibility of CT-guided percutaneous radionuclide therapy with the OncoSil* device in patients with non-progressive locally advanced pancreatic cancer (PANCOSIL): an open-label, single-arm phase 1-2 feasibility study - PANCOSIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54345

Enrollment

Registered

2023-06-01

Start date

2023-06-11

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Pancreatic Cancer Unresectable Pancreatic Cancer

Interventions

Eligible patients will undergo percutaneous ultrasound or CT-guided OncoSil* injection. The first five procedures will be performed under general anaesthesia. The following five cases hereafter will

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >=18 years - Locally advanced pancreatic cancer, defined by the DPCG consensus criteria as: arterial involvement >90* or venous involvement >270*. - At least RECIST stable disease after a minimum two months of chemotherapy according to current clinical practice* - Capable of providing written and oral informed consent - Candidate for RNT, judged by a multidisciplinary tumor board - WHO 0-2 * FOLFIRINOX for patients with WHO 0-1 performance status and gemcitabine-nab-paclitaxel for patients with > 1-2performance status.

Exclusion criteria

Exclusion criteria: - Eligibility for resection - Participation in other trials focussing on different ablative treatment modalities such as radiofrequency ablation or irreversible electroporation for LAPC - Bleeding disorders which cannot be corrected with medication - Inability/unwillingness to interrupt anticoagulation therapy - ASA 3/4 - Pregnancy - Metastatic pancreatic cancer - Epilepsy episode(s) in the past six months - Longest tumor diameter >70 mm or total target tumor volume >110 ml - Presence of multiple collateral vessels surrounding or adjacent to the target tumor on radiologic imagining, prohibiting safe injection of the OncosilTM device - Presence (or significant risk) of varices near the target tumor on radiologic imaging - Recent clinically significant pancreatitis - Previous administration of radiotherapy to the pancreas - WHO > 2

Design outcomes

Primary

Measure	Time frame
Safety and feasibility of percutaneous RNT using the Oncosil* device defined by the percentage of complications CTCAE grade 3 or higher.	—

Secondary

Measure	Time frame
• Technical success, defined as adequate puncture of the tumour and injection of the Oncosil* device, aiming at complete tumor ablation. • Non-serious events, defined as events with a CTCAE grade	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)