Trials / Terminated
TerminatedNCT05131776
EUS-guided Intra-tumour Injection of OncoSil for Locally Advanced Pancreatic Carcinoma.
Concurrent EUS-guided Intra-tumour Injection of OncoSil (32P) With Chemotherapy in Locally Advanced Pancreatic Carcinoma.
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Chinese University of Hong Kong · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EUS-guided oncosil injection | All patients will receive OncoSilTM during the 4th week of the first chemotherapy cycle. |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2021-11-23
- Last updated
- 2026-03-23
Locations
1 site across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT05131776. Inclusion in this directory is not an endorsement.