The purpose of the study is to assess the safety and efficacy of OncoSilâ„¢ when given in addition to standard FOLFIRINOX chemotherapy for treatment of Locally Advanced Pancreatic Cancer
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically proven adenocarcinoma of the pancreas.
✓. Unresectable locally advanced pancreatic adenocarcinoma according to NCCN 2021 guidelines.Staging and unresectability must be confirmed by central review of the baseline CT scan.
✓. Pancreatic target tumour diameter of \< 7.0 cm (longest axis), as qualified by the central reading centre.
✓. Karnofsky Performance Status ≥ 70
✓. ≥ 18 years of age at screening.
✓. Considered fit to commence first-line standard FOLFIRINOX chemotherapy:
✓. Provide signed Informed Consent.
✓. Willing and able to complete study procedures within the study timelines.
Exclusion criteria
✕. Evidence of distant metastases, based on review of baseline CT scan.
✕. More than one pancreatic tumour lesion.
✕. Any prior radiotherapy or chemotherapy for pancreatic cancer.
✕. Pregnant or lactating.
✕. In the opinion of the investigator, EUS-directed implantation posing undue study subject risk. This includes:
What they're measuring
1
Safety and Tolerability
Timeframe: Through study completion, an average of 18 months
2
Local Disease Control Rate (LDCR) at 16 Weeks
Timeframe: 16 weeks after initiation of FOLFOX chemotherapy
. 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 radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
✕. A known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components.