Locally Advanced Pancreatic CancerPhase 2TRIPP-FFXNCT05466799
FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma
A Phase 2 study testing FOLFIRINOX chemotherapy and OncoSil™ in people with Locally Advanced Pancreatic Cancer, run by OncoSil Medical Limited at 14 sites in 5 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- FOLFIRINOX chemotherapy and OncoSil™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 26 Apr 2023to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN).
- 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.
- 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.
Who cannot join
- 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:
- 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.
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- 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.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Spain6 sites
Hospital Universitari Vall d'Hebron
Barcelona
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario 12 de Octobre
Madrid
Hospital Universitario de Fuenlabrada
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Clínica Universidad de Navarra
Pamplona, 31008
United Kingdom4 sites
Guy's Hospital
London
The Christie Hospital/Manchester Royal Infirmary
Manchester
Freeman Hospital
Newcastle upon Tyne
University Hospital Southampton
Southampton
Italy2 sites
San Camillo Forlanini
Rome
Azienda Ospedaliera Universitaria Integrata Verona
Verona
About this study
Official title: 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.
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
Read the detailed description
Patients with Locally Advanced Pancreatic Cancer who have not received prior treatment to their pancreatic cancer will be informed about the study and the potential risks and benefits. After providing informed consent patients will undergo a 3 week screening period to confirm eligibility for the study. Patients who meet all eligibility criteria will be randomised 1:1 to either the control arm of up to 12 cycles of standard of care FOLFIRINOX chemotherapy or implantation of OncoSil™ in addition to the same FOLFIRINOX chemotherapy regimen. Patients will be followed for side side effects and palliative benefits during 4-8 weekly study visits and the objective efficacy of the treatment will be assessed by CT scans every 8 weeks. Quality of Life will be measured on various time-points using questionnaires.
- Conditions
- Locally Advanced Pancreatic Cancer
- Being tested
- FOLFIRINOX chemotherapy, OncoSil™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRINOX chemotherapyDrug
Also called Folinic Acid, 5-FU, Oxaliplatin, Irinotecan
Standard Of Care Chemotherapy regimen for treatment of Locally Advanced Pancreatic cancer
OncoSil™Device
Also called Phosphorous-32 microparticles
Implantation of OncoSil 32P microparticles into the Pancreatic Tumour under EUS guidance
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRINOX Chemotherapy | Active comparator | Subjects in Arm A will receive up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy Receives: 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 Receives: Drug: FOLFIRINOX chemotherapy; Device: OncoSil™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The primary analysis for safety of OncoSil™ is defined by the Adverse Event profile
Measured: 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
Measured: 16 weeks after initiation of FOLFOX chemotherapy
Secondary outcomes (12)
Local Progression Free Survival (LPFS), within the pancreas
Local Progression Free Survival (LPFS) is defined as the time from enrolment to the date of the radiological scan used to determine local tumour progression or date of death from any cause, whichever comes first.
Measured: 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
Progression free survival (PFS) is defined as the time from enrolment to the date of tumour progression or of recurrence (in case of complete response (CR) or resection of the primary pancreatic tumour), or death from any cause, whichever comes first.
Measured: 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
Time to symptomatic progression is defined as the time between enrolment and worsening of cancer related symptoms as measured by the symptoms domains of QLQ-C30/PAN26
Measured: 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
Clinical Benefit Response is a composite endpoint consisting of weight, Performance Status and pain score and will be derived at 4 weekly intervals.The frequency and percentage of subjects with a clinical benefit response will be summarised
Measured: 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
CA 19-19 response will be defined as ≥ 50% decline from baseline and ≥ 90% decline from baseline and return to normal range respectively. Subgroups will be created for study subjects with CA 19-9 > ULN at baseline.
Measured: 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
Overall Survival
Overall survival (OS) is the time from enrolment to the date of death from any cause.
Measured: Through study completion, an average of 18 months
Patient Reported Outcomes
EQ-5D, EORTC QLQ-C30 and PAN26 will be analyses per their validated methodology
Measured: Through study completion, an average of 18 months
Pain Scores
NRS and QLC-PAN26
Measured: 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
Weight loss
weight will be assessed at all applicable study visits
Measured: 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
Tumour response
RECIST 1.1 per central review
Measured: 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
Surgical resection rate
assessment of rate of secondary R0/R1 resection
Measured: Through study completion, an average of 18 months
Target Tumour Volumetric Change
A central reading centre will analyse all CT scans to measure target tumour volume changes from baseline.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start26 Apr 2023
- Primary completion26 Jan 2026
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoSil Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michele Milella, MD, PhD, Principal investigator, University Hospital of VeronaGiuseppe Malleo, MD, PhD, Principal investigator, University Hospital of Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466799
- Sponsor's protocol ID
- ONCO01P04
- Acronym
- TRIPP-FFX
- Status last verified
- Feb 2026
- First submitted
- 12 Jul 2022
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD may be shared on an individual basis to study investigators subject to review and approval from the study publication steering committee
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05466799
- Acronym / sponsor ID
- TRIPP-FFX / ONCO01P04
- Conditions
- Locally Advanced Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- OncoSil Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Patients with Locally Advanced Pancreatic Cancer who have not received prior treatment to their pancreatic cancer will be informed about the study and the potential risks and benefits. After providing informed consent patients will undergo a 3 week screening period to confirm eligibility for the study. Patients who meet all eligibility criteria will be randomised 1:1 to either the control arm of up to 12 cycles of standard of care FOLFIRINOX chemotherapy or implantation of OncoSil™ in addition to the same FOLFIRINOX chemotherapy regimen. Patients will be followed for side side effects and palliative benefits during 4-8 weekly study visits and the objective efficacy of the treatment will be assessed by CT scans every 8 weeks. Quality of Life will be measured on various time-points using questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFIRINOX Chemotherapy | Active comparator | Drug: FOLFIRINOX chemotherapySubjects in Arm A will receive up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy |
| OncoSil™ in addition to FOLFIRINOX Chemotherapy | Experimental | Drug: FOLFIRINOX chemotherapy, Device: OncoSil™Subjects in Arm B will be implanted with the OncoSil™ device in addition to up to 12 cycles of Standard Of Care FOLFIRINOX chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFIRINOX chemotherapyAlso: Folinic Acid, 5-FU, Oxaliplatin, IrinotecanStandard Of Care Chemotherapy regimen for treatment of Locally Advanced Pancreatic cancer | Drug | FOLFIRINOX Chemotherapy, OncoSil™ in addition to FOLFIRINOX Chemotherapy |
| OncoSil™Also: Phosphorous-32 microparticlesImplantation of OncoSil 32P microparticles into the Pancreatic Tumour under EUS guidance | Device | OncoSil™ in addition to FOLFIRINOX Chemotherapy |
Primary outcome
Safety and Tolerability
Time frame: Through study completion, an average of 18 months
The primary analysis for safety of OncoSil™ is defined by the Adverse Event profile
Local Disease Control Rate (LDCR) at 16 Weeks
Time frame: 16 weeks after initiation of FOLFOX chemotherapy
The LDCR at Week 16 will be summarised as a count and proportion of subjects with Local Disease Control at 16 Weeks
12 secondary outcomes
Local Progression Free Survival (LPFS), within the pancreas
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Overall Survival
Time frame: Through study completion, an average of 18 months
Patient Reported Outcomes
Time frame: Through study completion, an average of 18 months
Pain Scores
Time frame: 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
Weight loss
Time frame: 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
Tumour response
Time frame: 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
Surgical resection rate
Time frame: Through study completion, an average of 18 months
Target Tumour Volumetric Change
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Yes. IPD may be shared on an individual basis to study investigators subject to review and approval from the study publication steering committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Milella, MD, PhD principal investigator
University Hospital of Verona
Giuseppe Malleo, MD, PhD principal investigator
University Hospital of Verona
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFIRINOX chemotherapy and OncoSil™ in people with Locally Advanced Pancreatic Cancer, run by OncoSil Medical Limited at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, United Kingdom, Italy, Australia, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Through study completion, an average of 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.