FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma

NCT05466799 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: ONCO01P04
• Study Type: interventional
• Target: 88
• Locations: 5 countries
• Sites: 14

Brief Summary

The purpose of the study is to assess the safety and efficacy of OncoSil™ when given in addition to standard FOLFIRINOX chemotherapy for treatment of Locally Advanced Pancreatic Cancer

Conditions

Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability

  The primary analysis for safety of OncoSil™ is defined by the Adverse Event profile

  Through study completion, an average of 18 months

• Local Disease Control Rate (LDCR) at 16 Weeks

  The LDCR at Week 16 will be summarised as a count and proportion of subjects with Local Disease Control at 16 Weeks

  16 weeks after initiation of FOLFOX chemotherapy

Secondary Outcomes (12)

• Local Progression Free Survival (LPFS), within the pancreas

  From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient

• Progression Free Survival

  From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient

• Time to symptomatic progression

  From date of enrolment until the date of symptomatic progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient

• Clinical Benefit Response

  From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient

• CA 19-9 response

  From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 7 months after last enrolled patient

Study Arms (2)

FOLFIRINOX Chemotherapy

ACTIVE COMPARATOR

Subjects in Arm A will receive up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy

Drug: FOLFIRINOX chemotherapy

OncoSil™ in addition to FOLFIRINOX Chemotherapy

EXPERIMENTAL

Subjects in Arm B will be implanted with the OncoSil™ device in addition to up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy

Drug: FOLFIRINOX chemotherapy; Device: OncoSil™

Interventions

FOLFIRINOX chemotherapy DRUG

Standard Of Care Chemotherapy regimen for treatment of Locally Advanced Pancreatic cancer

Also known as: Folinic Acid, 5-FU, Oxaliplatin, Irinotecan

FOLFIRINOX Chemotherapy; OncoSil™ in addition to FOLFIRINOX Chemotherapy

OncoSil™ DEVICE

Implantation of OncoSil 32P microparticles into the Pancreatic Tumour under EUS guidance

Also known as: Phosphorous-32 microparticles

OncoSil™ in addition to FOLFIRINOX Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven adenocarcinoma of the pancreas.
• Unresectable locally advanced pancreatic adenocarcinoma according to NCCN 2021 guidelines.Staging and unresectability must be confirmed by central review of the baseline CT scan.
• Pancreatic target tumour diameter of \< 7.0 cm (longest axis), as qualified by the central reading centre.
• Karnofsky Performance Status ≥ 70
• ≥ 18 years of age at screening.
• 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.
• Provide signed Informed Consent.
• Willing and able to complete study procedures within the study timelines.
• Life expectancy of at least 3 months at the time of screening as judged by the investigator.
• 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.
• 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.

You may not qualify if:

• Evidence of distant metastases, based on review of baseline CT scan.
• More than one pancreatic tumour lesion.
• Any prior radiotherapy or chemotherapy for pancreatic cancer.
• Pregnant or lactating.
• 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.
• 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.
• Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
• A known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components.
• Any other health condition that would preclude participation in the study in the judgment of the investigator.

Sponsors & Collaborators

• OncoSil Medical Limited: lead

Study Sites (14)

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

AZ Maria Middelares

Ghent, Belgium

Location

San Camillo Forlanini

Rome, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario 12 de Octobre

Madrid, Spain

Location

Hospital Universitario de Fuenlabrada

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

Guy's Hospital

London, United Kingdom

Location

The Christie Hospital/Manchester Royal Infirmary

Manchester, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Location

University Hospital Southampton

Southampton, United Kingdom

Location

MeSH Terms

Interventions

Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Study Officials

• Michele Milella, MD, PhD

  University Hospital of Verona

  PRINCIPAL INVESTIGATOR

• Giuseppe Malleo, MD, PhD

  University Hospital of Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 20, 2022
• Study Start: April 26, 2023
• Primary Completion: January 26, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: After the release of the primary study publication
• Access Criteria: Request should be made to the chair of the publication steering committee with specification of the proposed analysis and the required IPD

Locations

IT (2); ES (6); GB (4); BE (1); AU (1)