Clinical trial · Interventional
32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer
A Phase IIa, Safety Study of the Active Implantable(Radiological) Medical Device 32P BioSilicon, Administered Intratumourally to Patients With Advanced, Unresectable Pancreatic Cancer, in Addition to Standard IV Gemcitabine Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is the first study investigating the safety of 32P BioSilicon in patients with advanced,unresectable pancreatic cancer who are also receiving standard intravenous gemcitabine chemotherapy. The secondary aims of the study will assess the implantation procedure, localisation of 32P BioSilicon, tumour response and survival parameters. Tumours targetted with 32P BioSilicon is hypothesized to show a reduction in tumour volume and with the low radioactivity dose that is delivered intratumourally, the incidence of side effects associated with the treatment is expected to be low. Prologation of survival and improved quality of life could be favourable outcomes of the investigational product.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 32P BioSilicon | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety profile of the patients defined by the Adverse Events profile.
Secondary outcomes (1)
- measure
- Will assess ease of use, tumour response, duration of response, progression free survival and overall survival. Target tumour response summaries for the study will be performed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: - * Histologically proven locally advanced or metastatic adenocarcinoma of the pancreas * Advanced pancreatic disease, not amenable to surgical resection * Measurable disease by CT scan, with a tumour burden equivalent to a diameter of no less than 3cm and no greater than 6cm * ECOG Performance status 0 - 2 * Life expectancy at least three months * Laboratory parameters: Hb greater than or equal to 10 g/dl Platelets greater than or equal to 100,000 mm3 ANC greater than or equal to 1500/mm3 Bilirubin \< 1.3 x ULN Alkaline phosphatase \< 5 x ULN Transaminases \< 5 x ULN Creatinine \< 1.5 x ULN Prothrombin (PT) and partial thromboplastin time (PTT) within normal range Serum calcium within normal range * All patients of reproductive potential must agree to use an effective barrier method of contraception during the study and for six months following termination of treatment. * Male and female patients aged 18 or over who have provided written informed consent Exclusion Criteria: - * Any previous treatment with 32 Phosphorus or with 32P BioSiliconTM * Any prior radiotherapy for pancreatic cancer * Use of other investigational agent at the time of enrolment, or within 30 days or five half-lives of enrolment, whichever is longer * History of hypersensitivity to any of the study products or to products with similar chemical structures (i.e. silicon or phosphorous) * History of malignancy of any other organ system, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of localised basal cell carcinoma of the skin and in situ cervical carcinoma * Pregnant or lactating women * Significant tumour related pain for which analgesic intervention incorporating epidural or EUS is planned
References
Publications (0)
Data not yet available