A Study of the Safety Profile of Three Escalating Radioactivity Levels of 32P BioSilicon Delivered With the SIMPL Needle as Intratumoural Implantations in Patients With Unresectable Hepatocellular Carcinoma
The study will enroll between 48 to 50 patients from all sites. Patients will be enrolled
sequentially into the three groups, starting wth Group 1 which will investigate the lower
radioactivity level and then progress to a higher radioactivity level in Group 2 and then
Group 3. The approval to enrol patients into the next group will be assessed and determined
by a Data Monitoring Board. All patients will be followed up to 52 weeks from the start date
of primary implantations.
Patients will receive intratumoural implantations of 32P BioSiliconTM under imaging guidance
and local anaesthesia by designated interventional radiologists, using the SIMPL needle or
conventional needles depending on the size and location of the tumour as assessed by the
designated interventional radiologists. There are only a designated number of sites that
will perform the implantation procedure although there are multiple sites recruiting and
following up with patients.
- Tumour assessment, tumour calculation and measurement will be performed by an
independent radiologist. CT scans from all participating sites will be sent in DICOM
format to the designated radiologist for assessment.
- Safety assessment and grading of CTCAE will be performed by the same investigator for
that same patient throughout the entire study period. There will be an interim analysis
when all patients complete 24 weeks evaluating the safety profile and target tumour
response of the patients.
- 32P BioSiliconTM will be prepared by designated personnel licensed to handle
radioactive products and all radioactive waste will be handed and managed as per the
institution's guidelines and in compliance with local regulatory requirements.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
This is a multicentre, open label study to evaluate the safety and efficacy of three escalating radioactivity levels (MBq) of 32P BioSiliconTM in patients with unresectable hepatocellular carcinoma
Singapore General Hospital
Singapore: Health Sciences Authority