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

NCT05131776 | Terminated Phase 2

• 1 other identifier: NTEC-2021-0234
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endoscopic Ultrasound; Pancreatic Cancer

Keywords

Pancreatic cancer; Endoscopic ultrasound

Outcome Measures

Primary Outcomes (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

  30 day

Secondary Outcomes (4)

• Overall survival

  5 years

• Local Disease Control Rate

  16 week

• Local Progression Free Survival

  6 months

• Progression Free Survival

  5 years

Study Arms (1)

EUS-guided oncosil injection

EXPERIMENTAL

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

Device: EUS-guided oncosil injection

Interventions

EUS-guided oncosil injection DEVICE

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

EUS-guided oncosil injection

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Surgery, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 18266048 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 23, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)