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Pancreatic CancerPhase 2/3NCT05131776

EUS-guided Intra-tumour Injection of OncoSil for Locally Advanced Pancreatic Carcinoma.

A Phase 2/3 study testing EUS-guided oncosil injection in people with Pancreatic Cancer and Endoscopic Ultrasound, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The outcomes of concurrent EUS-guided intra-tumour injection of P-32 microparticles (OncoSil; OncoSil Medical, Australia) with chemotherapy in locally advanced pancreatic carcinoma in the local population is uncertain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer, Endoscopic Ultrasound
What is being tested?
EUS-guided oncosil injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteHong Kong
Study dates
1 Nov 2021to 31 Dec 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

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

  • Study participants are ≥ 18 years of age at screening.
  • Histologically or cytologically proven adenocarcinoma of the pancreas.
  • Unresectable locally advanced pancreatic carcinoma. Patients with technically resectable tumours (T1-T3) will also be eligible, if they are deemed unresectable due to medical comorbidities or refusal of surgery.
  • Pancreatic target tumour diameter ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest axis)
  • An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100.
  • Willing and able to complete study procedures within the study timelines.
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  • 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) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, haemoglobin ≥ 9 g/dL, and platelets ≥ 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.
  • Technically feasible - tumour must be within reach of the EUS probe for fine needle Injection.

Who cannot join

  • 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 1, whichever is longer.
  • 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 tumour invasion into stomach, duodenum or peritoneum
  • In the opinion of the investigator, EUS directed implantation posing undue study participant risk. This includes:
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  • Where previous EUS-FNA was considered technically too difficult to perform;
  • Imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;
  • Presence (or significant risk) of varices near to the target tumour.
  • A known allergy or history of hypersensitivity to silicon, Phosphorus or any of the OncoSil™ components.
  • Patients who do not consent to chemotherapy
  • Actively on medication that increase bleeding risk (i.e. aspirin, clopidogrel, warfarin, NOAC).
  • Any other health condition that would preclude participation in the study in the judgment of the investigator.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Department of Surgery, Prince of Wales Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Concurrent EUS-guided Intra-tumour Injection of OncoSil (32P) With Chemotherapy in Locally Advanced Pancreatic Carcinoma.

The outcomes of concurrent EUS-guided intra-tumour injection of P-32 microparticles (OncoSil; OncoSil Medical, Australia) with chemotherapy in locally advanced pancreatic carcinoma in the local population is uncertain.

The aim of the current study is to assess efficacy and safety of the intervention in the local population. We hypothesis that the intervention is safe and useful for tumour downstaging.

Read the detailed description

This would be a cohort study including patients with locally advanced pancreatic cancer medically fit to receive chemotherapy. Eligible patients would receive gemcitabine (GNP; 28- day cycles). P-32 microparticles (OncoSil; OncoSil Medical) implantation will be planned at weeks 4-5. P-32 activity will be calculated from patients' tumor volume (TV) to deliver 100 Gy absorbed dose, with implantation assessment by EUS and Bremsstrahlung SPECT/CT imaging. The primary endpoint was safety and tolerability, graded using CTCAE v4.0. Response will be assessed using RECIST 1.1 with 8-weekly CT scans and FDG-PET scans at baseline and week 12. The outcome parameters include adverse events, response of the tumour, local progression free survival and overall survival (OS).

Being tested
EUS-guided oncosil injection
Keywords
Pancreatic cancer, Endoscopic ultrasound
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EUS-guided oncosil injectionDevice

    All patients will receive OncoSilTM during the 4th week of the first chemotherapy cycle.

Study groups in NCT05131776
Study groupRoleWhat they receive
EUS-guided oncosil injectionExperimentalAll patients will receive OncoSilTM during the 4th week of the first chemotherapy cycle.
Receives: Device: EUS-guided oncosil injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Any untoward medical occurrence, unintended disease or injury, oruntoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device

    Measured: 30 day

Secondary outcomes (4)

  1. Overall survival

    Overall survival of the patient

    Measured: 5 years

  2. Local Disease Control Rate

    proportion of study participants whose local tumour response is stable disease (SD), partial response (PR), or complete response (CR)

    Measured: 16 week

  3. Local Progression Free Survival

    the time from enrolment to the date of the radiological scan used to determine local tumour progression or date of death, whichever comes first.

    Measured: 6 months

  4. Progression Free Survival

    the time from enrolment to the date of tumour progression or of recurrence (in case of complete response (CR))

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study start1 Nov 2021
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Why it stopped: Inadequate funding

Resources

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 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
OncoSil™ is comprised of OncoSil Phosphorous-32 Microparticles (hereafter Microparticles) and OncoSil Diluent (hereafter Diluent). OncoSil™ is an active implantable (radiological) medical device intended for use in brachytherapy, where cancer is treated by the insertion of radioactive implants directly into the cancerous tissue. OncoSil™ has been designed to be injected directly into, and to deliver an average absorbed dose of 100 Gy to the target treatment tumour. In therapeutic use 98% of the radiation is delivered within 81 days.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05131776
Sponsor's protocol ID
NTEC-2021-0234
Status last verified
Mar 2026
First submitted
12 Nov 2021
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan

Publications

  • Rosemurgy A, Luzardo G, Cooper J, Bowers C, Zervos E, Bloomston M, Al-Saadi S, Carroll R, Chheda H, Carey L, Goldin S, Grundy S, Kudryk B, Zwiebel B, Black T, Briggs J, Chervenick P. 32P as an adjunct to standard therapy for locally advanced unresectable pancreatic cancer: a randomized trial. J Gastrointest Surg. 2008 Apr;12(4):682-8. doi: 10.1007/s11605-007-0430-6. Epub 2008 Feb 12.

    PubMed 18266048

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing EUS-guided oncosil injection in people with Pancreatic Cancer and Endoscopic Ultrasound, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 13 inclusion and 13 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: stopped early, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Inadequate funding). Results are not available in the source record.

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?

Adverse events (time frame: 30 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05131776, which also lists 1 linked publication.

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 23 Mar 2026.

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