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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2024
  • participants needed
    20
  • sponsor
    Chinese University of Hong Kong
Updated on 29 November 2021
carcinoma
karnofsky performance status
probe
neutrophil count
cancer chemotherapy
adenocarcinoma

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).

Details
Condition cancer, pancreatic, pancreatic cancers, Endoscopic Ultrasound, Pancreatic Disorders, Pancreatic disorder, Neoplasm of unspecified nature of digestive system, cancer of the pancreas, Islet Ce417ll Cancer, Digestive System Neoplasms, endoscopic ultrasonography, Pancreatic Cancer
Treatment EUS-guided oncosil injection
Clinical Study IdentifierNCT05131776
SponsorChinese University of Hong Kong
Last Modified on29 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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 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
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