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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

Phase 2
18 Years
Open (Enrolling)
Liver Cancer

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Trial Information

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.

Inclusion Criteria:

1. Written informed consent.

2. Male or female patients equal to or greater than 18 years old.

3. Patients with diagnosis of hepatocellular carcinoma (HCC) meeting one of the criteria

1. Histology OR

2. Radiological evidence'*' of HCC demonstrated by dynamic contrast enhanced
computed tomography (CT) or dynamic contrast enhanced magnetic resonance imaging
(MRI) >/ 1cm AND serum AFP of at least 400 mcg/L OR

3. Radiological evidence'*' of HCC demonstrated by dynamic contrast CT or dynamic
contrast enhanced MRI >/ 1cm AND serology positive for hepatitis B or C

'*' Criteria for radiological evidence of HCC are: central enhancement on hepatic
arterial phase AND wash out on portal venous or delayed phase.

4. Hepatic tumour mass not amenable to surgical resection or patient refuses surgery.

5. ECOG performance status 0 - 2.

6. Okuda stage I - II

7. Total volume of any single treatable tumour not more than 65 cc (not more than
approximately 5 cm in longest dimension).

8. Total treatable volume of not more than 125 cc (Group 1), 111 cc (Group 2), 139 cc
(Group 3) - as defined by maximum radioactivity level (MBq) for the respective

9. Adequate haematological, renal and hepatic functions as defined by the following
laboratory values obtained within 14 days prior to Visit 2

- Absolute granulocyte count (AGC) >/1500 cells/mm3

- Serum creatinine < 2 times upper limit of normal (ULN)

- Serum bilirubin < 3 times ULN

- ALT (SGPT) < 5 times ULN and/or AST (SGOT)
< 5 times ULN within 24 hours prior to implantation (Supportive care and
correction permitted) Platelet count >/ 60,000/mm3 (60 x

- Prothrombin time < 3 seconds prolonged

10. Women of childbearing potential must have a negative urine pregnancy test within
three days of Visit 2.

11. Contraception must be used (both male and female) for six months after implantation
and during the duration of the whole study.

12. Patients must be accessible for treatment and follow up.

Exclusion Criteria:

1. Clinical encephalopathy

2. Patients younger than 18 years old.

3. No life threatening tumours in other sites (e.g. brain)

4. Less than four weeks after local therapy with radiofrequency ablation (RFA), or
ethanol, and less than six weeks after local therapy with transarterial
chemoembolization therapy (TACE), or since prior chemotherapy or biologic therapy
(e.g. immunotherapy, systemic vaccine therapy).

5. Prior radiotherapy to liver, pancreas or gastrointestinal tract.

6. Total volume for each tumour is greater than 65 cc (greater than approximately 5 cm
in longest dimension).

7. Amenable to surgery.

8. Pregnant or lactating females.

9. Other diagnosed malignancy within the last five years, which may impact on study

10. Life expectancy of less than 12 weeks.

11. Patients with a significant history of cardiac disease, that is, uncontrolled high
blood pressure, unstable angina, congestive heart failure, myocardial infarction
within the past three months and cardiac ventricular arrhythmias requiring

12. Patients with serious active infection or other serious underlying medical conditions
that would impair the ability of the patient to receive protocol treatment at
implantation visits.

13. Patients with any condition (e.g. psychological) that does not permit compliance with
the protocol.

14. Patients who are known to be HIV positive. Testing is not required in the absence of
clinical signs and symptoms suggestive of HIV infection.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Pierce Chow

Investigator Role:

Principal Investigator

Investigator Affiliation:

Singapore General Hospital


Singapore: Health Sciences Authority

Study ID:




Start Date:

October 2005

Completion Date:

February 2007

Related Keywords:

  • Liver Cancer
  • HCC
  • Primary Liver Cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular