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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05131776
Other study ID # NTEC-2021-0234
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date November 1, 2021
Est. completion date October 31, 2024

Study information

Verified date February 2023
Source Chinese University of Hong Kong
Contact Anthony YB Teoh, FRCSEd
Phone 35052956
Email anthonyteoh@surgery.cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 OncoSilâ„¢ 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.

Study Design


Intervention

Device:
EUS-guided oncosil injection
All patients will receive OncoSilTM during the 4th week of the first chemotherapy cycle.

Locations

Country Name City State
Hong Kong Department of Surgery, Prince of Wales Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall survival Overall survival of the patient 5 years
Secondary Local Disease Control Rate proportion of study participants whose local tumour response is stable disease (SD), partial response (PR), or complete response (CR) 16 week
Secondary 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. 6 months
Secondary Progression Free Survival the time from enrolment to the date of tumour progression or of recurrence (in case of complete response (CR)) 5 years
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