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A Phase II Study for the Treatment of Unresectable or Medically Inoperable Hepatocellular Carcinoma Using Stereotactic Body Radiotherapy (SBRT) in British Columbia

Phase 2
18 Years
Not Enrolling
Unresectable Hepatocellular Carcinoma

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Trial Information

A Phase II Study for the Treatment of Unresectable or Medically Inoperable Hepatocellular Carcinoma Using Stereotactic Body Radiotherapy (SBRT) in British Columbia

Radiotherapy is not considered standard of care practice for patients for inoperable
hepatocellular carcinoma despite the tumour's inherent radiosensitivity. The major challenge
has been improving radiation delivery without exceeding dose limits of the surrounding
normal liver. Recent technological advances with tumour localization and targeting, imaging,
treatment planning and delivery have allowed for safe delivery of radiation with tumorcidal
effect and minimal treatment-related toxicity.

This study has three specific aims:

1. To develop, validate, and quality test HDR Stereotactic Body Radiotherapy (SBRT) Gated
RapidArc technique for application in human liver tumours. And furthermore, to test whether
HDR SBRT Gated RapidArc can be efficiently and safely delivered to a very large patient
population previously ineligible for any therapy (HCC patients with tumours >5cm).

3. To determine if 11C-choline/18F-FDG CT-PET or perfusion CT imaging (that characterize
changes in tumour proliferation, glycolysis, and vasculature, respectively) can provide
practical non-invasive biomarkers of tumour response, local tumour control, or normal tissue

4. To determine if immunologic studies of pre- and post-treatment blood samples can provide
biomarkers of tumour response, local and systemic tumour control, or triggers for normal
tissue toxicity.

Inclusion Criteria:

1. Age > 18 years old

2. Multi-phase CT scan of the liver within 8 weeks of radiation planning demonstrating:

- Liver tumours must be > 5 cm

- No more than 5 discrete liver tumours may be present

- Normal liver > 700 cc

3. FDG-PET scan within 12 weeks prior to radiation planning

4. Patients must have HCC diagnosed by either: i) pathological confirmation, or ii)
intrahepatic vascular enhancement of the lesion demonstrated by at least two imaging
modalities, or iii) intrahepatic vascular enhancement of the lesion demonstrated by
one imaging modality if AFP > 200 in the setting of liver cirrhosis or chronic
hepatitis B without cirrhosis (EASL consensus guidelines)

5. Liver HCC must be deemed unresectable as determined by an experienced liver surgeon,
or the patient must be medically inoperable or refuse surgery, and extra-hepatic
metastases must not be present (Patients with potential resectable tumours who are
deemed unresectable based on medical inoperability or simultaneous extra-hepatic
metastases will be eligible to receive SBRT).

6. Patients must be discussed in a multidisciplinary setting where opinions regarding
radiofrequency ablation, various embolotherapies, and targeted biologics are
considered, but not eligible for. Patients must have recovered from the effects of
previous therapies before SBRT.

7. Eastern Clinical Oncology Group performance status 0,1 or 2 or a Karnofsky
performance status of ≥ 60

8. Adequate organ function as assessed by the following blood work:

- Hemoglobin ≥ 90 g/L

- Absolute neutrophil count ≥ 1.0 bil/L

- Platelets ≥ 50 bil/L

- AST and ALT not to exceed 2x upper limit of normal

9. Child-Turcotte-Pugh assessment (within 8 weeks of treatment date):

- Bilirubin ≤ 3 mg/dL (< 50 µmol/L)

- Albumin above 28 g/L

- INR < 1.7 and/or correctable with vitamin K (unless on anticoagulation therapy)

- No ascites or encephalopathy

- Child-Turcotte-Pugh score must be ≤ 7 (see Table 1 in Section 2.1)

10. BCLC Stage B or C (portal venous invasion or liver hilum nodal disease only)

11. No extra-hepatic disease and life expectancy > 6 months

12. No chemotherapy concurrent with radiotherapy

13. Previous treatment(s) with radiofrequency ablation, surgery, TACE, Y90, percutaneous
ethanol injection, or chemotherapy are not exclusion criteria provided that
recurrence has been documented.

14. Patient signs a study-specific informed consent form. If the patient's mental status
precludes this, written informed consent may be given by the patient's legal
representative. A translator will be provided if the patient has a language barrier.

15. Treatment plans meet acceptable dose constraints and Liver Veff is ≤ 0.55

Exclusion Criteria:

1. Patients with active hepatitis, encephalopathy, or ascites related to liver failure

2. Female patients who are pregnant (verify with blood test if patient is
pre-menopausal). Pre-menopausal patients may also not become pregnant during
participation in this study.

3. Prior external beam radiation to the upper abdomen

4. Patients with distant metastases or extrahepatic nodal progression (patients with
portal venous thrombosis and liver hilum nodal involvement remain eligible)

5. Patients who have < 700 cc of normal liver.

6. Child-Turcotte-Pugh scores > 7

7. BCLC Stage A, C (N1 and/or M1), D

8. Prior gastric, duodenal, or variceal bleed within the past 2 months

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

One year local progression-free rate

Outcome Time Frame:

Approximately 1 year

Safety Issue:


Principal Investigator

Mohamed Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency


Canada: Health Canada

Study ID:




Start Date:

July 2013

Completion Date:

August 2020

Related Keywords:

  • Unresectable Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular