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

2021-11-01

2024-10-31

2024-10-31

20

Study Overview

EUS-guided Intra-tumour Injection of OncoSil for 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.

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).

  • Pancreatic Cancer
  • Endoscopic Ultrasound
  • DEVICE: EUS-guided oncosil injection
  • NTEC-2021-0234

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2021-11-12  

N/A  

2023-02-06  

2021-11-22  

N/A  

2023-02-08  

2021-11-23  

N/A  

2023-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: EUS-guided oncosil injection

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

DEVICE: EUS-guided oncosil injection

  • All patients will receive OncoSilTM during the 4th week of the first chemotherapy cycle.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Adverse eventsAny 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 device30 day
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Overall survivalOverall survival of the patient5 years
Local Disease Control Rateproportion of study participants whose local tumour response is stable disease (SD), partial response (PR), or complete response (CR)16 week
Local Progression Free Survivalthe time from enrolment to the date of the radiological scan used to determine local tumour progression or date of death, whichever comes first.6 months
Progression Free Survivalthe time from enrolment to the date of tumour progression or of recurrence (in case of complete response (CR))5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Anthony YB Teoh, FRCSEd

Phone Number: 35052956

Email: anthonyteoh@surgery.cuhk.edu.hk

Study Contact Backup

Name: Zero Chung

Phone Number: 35052956

Email: zerochung@surgery.cuhk.edu.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Study participants are ≥ 18 years of age at screening. 2. Histologically or cytologically proven adenocarcinoma of the pancreas. 3. 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. 4. Pancreatic target tumour diameter ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest axis) 5. An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100. 6. Willing and able to complete study procedures within the study timelines. 7. Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN). 8. 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. 9. 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. 10. Life expectancy of at least 3 months at the time of screening as judged by the investigator. 11. 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. 12. Provide signed Informed Consent. 13. Technically feasible - tumour must be within reach of the EUS probe for fine needle Injection.
    Exclusion Criteria:
    1. More than one primary lesion. 2. Any prior radiotherapy or chemotherapy for pancreatic cancer. 3. 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. 4. 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. 5. Evidence of tumour invasion into stomach, duodenum or peritoneum 6. In the opinion of the investigator, EUS directed implantation posing undue study participant risk. This includes:
    1. Where previous EUS-FNA was considered technically too difficult to perform; 2. Imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas; 3. Presence (or significant risk) of varices near to the target tumour. 7. A known allergy or history of hypersensitivity to silicon, Phosphorus or any of the OncoSil™ components. 8. Patients who do not consent to chemotherapy 9. Actively on medication that increase bleeding risk (i.e. aspirin, clopidogrel, warfarin, NOAC). 10. Any other health condition that would preclude participation in the study in the judgment of the investigator.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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