Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001051336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
27/07/2026
Date registered
Help: Date registered
26/08/2026
Date last updated
Help: Date last updated
26/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
26/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A study of targeted internal radiation treatment (OncoSil™) with chemotherapy, with or without immunotherapy, for people with metastatic pancreatic cancer.
Scientific title
Impact of intra-tumour phosphorus-32 implantation in metastatic pancreatic adenocarcinoma
Additional trial identifiers [1] 318024 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Metastatic Pancreatic Cancer 343027 0
Condition category
Condition code
Cancer 339124 339124 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1 – OncoSil™ plus chemotherapy
Participants will receive standard-of-care chemotherapy together with a single implantation of OncoSil™ (phosphorus-32 microparticles) into the primary pancreatic tumour. The OncoSil™ implant will be performed approximately 4 weeks after commencing chemotherapy using endoscopic ultrasound (EUS)-guided implantation by experienced gastroenterologists/endosonographers trained in the OncoSil™ procedure at the Royal Adelaide Hospital. Chemotherapy will continue according to standard clinical practice. Participants will attend scheduled follow-up visits for clinical review, imaging, blood sample collection, and completion of study questionnaires. Adherence to study assessments will be monitored by the study team, with appointment reminders provided where required.

Arm 2 – OncoSil™ plus chemotherapy and immunotherapy
Participants will receive standard-of-care chemotherapy together with a single EUS-guided OncoSil™ implantation as described for Arm 1. Participants will also receive immunotherapy (nivolumab) administered according to the treating oncologist's prescribed schedule and institutional clinical practice. Immunotherapy will be delivered in the oncology outpatient setting by appropriately qualified oncology staff. Participants will undergo the same study assessments and follow-up schedule as Arm 1. Study visit adherence will be monitored by the research team.

For participants allocated to Arm 1 or Arm 2, the dose of OncoSil will be calculated prior to the procedure to achieve an Implanted Volume/Tumour Volume of 8% to deliver a dose of 100Gy to the tumour mass. Standard of care diagnostic imaging pre-chemotherapy will be accessed to assist with dose calculations, and on the day of the procedure the dose can be adjusted if the endoscopist determines if the tumour volume has increased/decreased since prior tumour volume assessment.

For participants allocated to Arm 2, the dose of nivolumab will be approximately 240mg, and provided every 2 weeks for about 6 months.

Intervention fidelity will be assessed through review of medical records, procedural reports, and treatment records. OncoSil implantation details will be documented by the treating endoscopist/investigator. Post-implantation Bremsstrahlung SPECT/CT imaging will be performed same day to confirm localisation of implanted OncoSil. The participants adherence to chemotherapy and immunotherapy schedules will be assessed through review of hospital administration records.
Intervention code [1] 334898 0
Treatment: Devices
Intervention code [2] 335165 0
Treatment: Other
Description of the comparator or control
Arm 3 – Chemotherapy alone (Control)
Participants will receive standard-of-care chemotherapy as determined by their treating medical oncologist. Chemotherapy regimen, dose, schedule and duration will be administered according to routine clinical practice at the treating hospital. Participants will undergo study-specific assessments including clinical review, blood sample collection, imaging, quality of life and pain questionnaires, and follow-up in accordance with the study schedule.

All patients in Arms 1-3 will approximately receive the same dose of chemotherapy, administered as modified FOLFIRINOX (mFOLFIRINOX).
One administration/cycle of mFOLFIRINOX consists of the following:
1. Oxaliplatin (85 mg/m2) + Irinotecan (150 mg/m2) + Calcium folinate (Leucovorin) (50mg), administered over ~5 hours;
2. Fluorouracil, 2400 mg/m2, administered for about 46 hours by pump at home.
Frequency will be once every 2 weeks, for 12 cycles.
Control group
Active

Outcomes
Primary outcome [1] 346365 0
Tumour size changes in the primary pancreatic tumour.
Timepoint [1] 346365 0
Baseline, approximately 8 weeks and 12 weeks following OncoSil™ implantation (or equivalent timepoints for the chemotherapy-alone group)
Primary outcome [2] 346578 0
Tumour size changes in the metastatic lesions
Timepoint [2] 346578 0
Baseline, approximately 8 weeks and 12 weeks following OncoSil™ implantation (or equivalent timepoints for the chemotherapy-alone group)
Secondary outcome [1] 465523 0
Overall response rate
Timepoint [1] 465523 0
At Screening and approximately 12 weeks following OncoSil™ implantation
Secondary outcome [2] 465524 0
Local immune response
Timepoint [2] 465524 0
Baseline and post-treatment tissue samples (where available)
Secondary outcome [3] 465525 0
Systemic immune response
Timepoint [3] 465525 0
At 4, 12, and 16 weeks from baseline chemotherapy commencement (Week 0).
Secondary outcome [4] 465526 0
Progression-free survival
Timepoint [4] 465526 0
Throughout follow-up (up to 12 months post chemotherapy commencment)
Secondary outcome [5] 465527 0
Overall survival
Timepoint [5] 465527 0
Until death or 104 weeks after enrolment of the final participant
Secondary outcome [6] 465528 0
Quality of Life
Timepoint [6] 465528 0
Baseline, 8 weeks and 12 weeks after implantation (or equivalent control timepoints)
Secondary outcome [7] 465529 0
Safety and tolerability (assessed as a composite outcome).
Timepoint [7] 465529 0
Throughout the study and follow-up up to 12 months post chemotherapy commencement (Week 0).
Secondary outcome [8] 465530 0
Change in Cancer Antigen (CA) 19-9
Timepoint [8] 465530 0
Screening, Baseline (Week 0 - chemotherapy commencement), and follow up visits at weeks 4, 12, and 16 post chemotherapy commencement.

Eligibility
Key inclusion criteria
-Histologically or cytologically proven adenocarcinoma of the pancreas.
-Pancreatic ductal adenocarcinoma with oligo-metastasis (< 5 lesions in liver, < 3 lesions in lung)
-Pancreatic target tumour diameter of less than/equal to 6.0 cm (longest axis)
-An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 – 100.
-Standard chemotherapy will be commenced within 14 days post enrolment.
-Willing and able to complete study procedures within the study timelines.
-Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN).
-Adequate liver function: Serum SGOT/AST and serum SGPT/SLT < 3 times ULN and serum bilirubin <1.5 times the ULN unless the patient is known to have prior Gilbert’s Syndrome.
-Adequate bone marrow function: white blood cells (WBCs) greater than/equal to 3,000/mm3, absolute neutrophil count (ANC) greater than/equal to 1,500/mm3, haemoglobin greater than/equal to 9 g/dL, and platelets greater than/equal to 100,000/mm3.
-Life expectancy of at least 3 months at the time of screening as judged by the investigator.
-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.
-Provide signed Informed Consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
-More than one primary lesion.
-Any prior radiotherapy or chemotherapy for pancreatic cancer.
-Use of other investigational agent at the time of screening, or within 30 days or five half-lives of Screening Visit, whichever is longer.
-Pregnant or lactating.
-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 more than 2 metastatic sites or peritoneal metastasis with ascites.
-Patients who do not consent to chemotherapy
-Any other health condition that would preclude participation in the study in the judgment of the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 322575 0
Hospital
Name [1] 322575 0
Royal Adelaide Hospital
Country [1] 322575 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 325500 0
None
Name [1] 325500 0
Address [1] 325500 0
Country [1] 325500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321047 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 321047 0
Ethics committee country [1] 321047 0
Australia
Date submitted for ethics approval [1] 321047 0
02/07/2026
Approval date [1] 321047 0
27/07/2026
Ethics approval number [1] 321047 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152490 0
Prof Nam Nguyen
Address 152490 0
Royal Adelaide Hospital, Port Road, Adelaide SA 5000
Country 152490 0
Australia
Phone 152490 0
+61 8 70742142
Fax 152490 0
Email 152490 0
[email protected]
Contact person for public queries
Name 152491 0
Joshua Zobel
Address 152491 0
Royal Adelaide Hospital, Port Road, Adelaide SA 5000
Country 152491 0
Australia
Phone 152491 0
+61 8 70742188
Fax 152491 0
Email 152491 0
[email protected]
Contact person for scientific queries
Name 152492 0
Joshua Zobel
Address 152492 0
Royal Adelaide Hospital, Port Road, Adelaide SA 5000
Country 152492 0
Australia
Phone 152492 0
+61 8 70742188
Fax 152492 0
Email 152492 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.