EUS-guided Intra-tumour Injection of OncoSil for Locally Advanced Pancreatic Carcinoma. (NCT05131776) | Clinical Trial Compass
TerminatedPhase 2/3
EUS-guided Intra-tumour Injection of OncoSil for Locally Advanced Pancreatic Carcinoma.
Stopped: Inadequate funding
Hong Kong2 participantsStarted 2021-11-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
✕. 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;