Comparing FOLFIRINOX with and without OncoSil™ for advanced pancreatic cancer

An Open-label, Multi-centre, Randomized Study of TaRgeted Intratumoural Placement of P-32 (OncoSil™) in Addition to FOLFIRINOX Chemotherapy vs FOLFIRINOX Alone in Patients With Unresectable Locally Advanced Pancreatic Adenocarcinoma.

This study is testing if adding OncoSil™ to the standard FOLFIRINOX chemotherapy helps people with advanced pancreatic cancer feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: OncoSil Medical Limited (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 17 sites (Adelaide, South Australia and 16 other locations)
• Trial ID: NCT05466799 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of adding OncoSil™ to the standard FOLFIRINOX chemotherapy regimen in patients with locally advanced pancreatic adenocarcinoma who have not previously received treatment. Eligible patients will undergo a screening period followed by randomization into two groups: one receiving standard FOLFIRINOX and the other receiving FOLFIRINOX with OncoSil™. Participants will be monitored for side effects and quality of life, with efficacy assessed through regular CT scans. The study aims to provide insights into the potential benefits of combining these treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable locally advanced pancreatic adenocarcinoma and a Karnofsky Performance Status of 70 or higher.

Not a fit: Patients with resectable pancreatic cancer or those who have previously received treatment for their cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with locally advanced pancreatic cancer.

How similar studies have performed: While the combination of FOLFIRINOX and OncoSil™ is a novel approach, similar studies have shown promise in enhancing treatment efficacy for pancreatic cancer.

Eligibility criteria

Inclusion Criteria:

1. Histologically or cytologically proven adenocarcinoma of the pancreas.
2. Unresectable locally advanced pancreatic adenocarcinoma according to NCCN 2021 guidelines.Staging and unresectability must be confirmed by central review of the baseline CT scan.
3. Pancreatic target tumour diameter of \< 7.0 cm (longest axis), as qualified by the central reading centre.
4. Karnofsky Performance Status ≥ 70
5. ≥ 18 years of age at screening.
6. Considered fit to commence first-line standard FOLFIRINOX chemotherapy:

   i) Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN).

   ii) Adequate liver function: serum liver transaminases ≤ 3 x ULN and serum bilirubin ≤ 1.5 x ULN\*.

   \*For study participants with recent biliary obstruction treated by drainage (e.g. stent), serum bilirubin of \> 1.5 x ULN will be accepted for study entry provided that serial levels demonstrate clear improvement. In addition, chemotherapy should not be commenced until serum bilirubin is ≤ 1.5 x ULN.

   iii) Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, haemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mm3 iv) UGT1A1 polymorphism and DPD deficiency test performed and dose reductions applied as per local institutional practice.
7. Provide signed Informed Consent.
8. Willing and able to complete study procedures within the study timelines.
9. Life expectancy of at least 3 months at the time of screening as judged by the investigator.
10. Treated with or eligible to commence prophylactic treatment with a proton-pump inhibitor prior to implantation, and to continue to receive treatment for at least 6 months post implantation.
11. Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the study and agrees not to donate sperm or ova, for the duration of the study and 12 months post implantation of the investigational device.

Exclusion Criteria:

1. Evidence of distant metastases, based on review of baseline CT scan.
2. More than one pancreatic tumour lesion.
3. Any prior radiotherapy or chemotherapy for pancreatic cancer.
4. Pregnant or lactating.
5. In the opinion of the investigator, EUS-directed implantation posing undue study subject risk. This includes:

   i) where previous EUS-FNA was considered technically too difficult to perform; ii) imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas; iii) presence (or significant risk) of varices near to the target tumour. Note: The feasibility of implantation of the target tumour and assessment of risk can be repeated at any time between Screening Visit 1 and the implantation date. If any of the above risk features becomes apparent following subject screening and/or enrolment prior to and including at the time of OncoSil™ treatment, the patient should remain in the study but the implantation should be deferred or cancelled.
6. History of malignancy, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
7. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
8. A known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components.
9. Any other health condition that would preclude participation in the study in the judgment of the investigator.

Where this trial is running

Adelaide, South Australia and 16 other locations

• Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
• Epworth Healthcare — Richmond, Victoria, Australia (Not_yet_recruiting)
• AZ Maria Middelares — Ghent, Belgium (Recruiting)
• San Camillo Forlanini — Rome, Italy (Recruiting)
• Azienda Ospedaliera Universitaria Integrata Verona — Verona, Italy (Recruiting)
• Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
• Hospital General Universitario Gregorio Marañón — Madrid, Spain (Recruiting)
• Hospital Universitario 12 de Octobre — Madrid, Spain (Recruiting)
• Hospital Universitario de Fuenlabrada — Madrid, Spain (Recruiting)
• Hospital Universitario Ramón y Cajal — Madrid, Spain (Recruiting)
• Clínica Universidad de Navarra — Pamplona, Spain (Recruiting)
• Hospital Universitari i Politècnic La Fe — Valencia, Spain (Not_yet_recruiting)
• Guy's Hospital — London, United Kingdom (Not_yet_recruiting)
• Imperial College — London, United Kingdom (Recruiting)
• The Christie Hospital/Manchester Royal Infirmary — Manchester, United Kingdom (Recruiting)
• Freeman Hospital — Newcastle Upon Tyne, United Kingdom (Recruiting)
• University Hospital Southampton — Southampton, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Michele Milella, MD, PhD — University Hospital of Verona
• Study coordinator: Henk Tissing

Conditions Locally Advanced Pancreatic Cancer