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

Pancreatic Cancer Clinical Trial

Official title:
Concurrent EUS-guided Intra-tumour Injection of OncoSil (32P) With Chemotherapy in Locally Advanced Pancreatic Carcinoma.

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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05131776
Study type Interventional
Source Chinese University of Hong Kong
Contact Anthony YB Teoh, FRCSEd
Phone 35052956
Email anthonyteoh@surgery.cuhk.edu.hk
Status Recruiting
Phase Phase 2/Phase 3
Start date November 1, 2021
Completion date October 31, 2024
View Details
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