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Phase II Study of Combination Stereotactic Body Radiotherapy (SBRT) With Transarterial Chemo-Embolization (TACE) for Unresectable Hepatocellular Carcinoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Carcinoma, Hepatocellular, Hepatobiliary Neoplasm, Liver Carcinoma

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Trial Information

Phase II Study of Combination Stereotactic Body Radiotherapy (SBRT) With Transarterial Chemo-Embolization (TACE) for Unresectable Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is
primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors
include alcoholic cirrhosis.

Outcome of this disease is poor, mostly due to the fact that >80% of patients present with
unresectable disease. Surgery or transplantation remain the only curative options. For the
vast majority of patients who are unresectable, a variety of treatment options are
available, including transarterial chemo-embolization (TACE), radiofrequency ablation,
radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and
percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body
radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available
because of great improvements in diagnostic imaging and radiation delivery techniques.
Although follow-up is limited, results show encouraging local control rates. Some
investigators have combined TACE with fractionated radiotherapy as a means of intensifying
local therapy, with some evidence of benefit.

TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence
rates are high. The recent randomized trial suggests that a combination of local therapy
(TACE and radiofrequency ablation [RFA]) is superior to either therapy alone, providing
proof of principle that combined local treatment is most likely more effective for HCC.
Because SBRT is rapidly becoming an accepted local therapy for hepatic lesions, its role in
treating HCC needs to be further defined. Studies combining TACE and external beam
radiotherapy have shown encouraging results, so the logical next step is to combine TACE
with SBRT, which delivers a radiobiologically more intensive dose of radiation. However,
toxicity data are lacking, since this combination has not been previously reported.

We propose to conduct a trial of trans-arterial chemo-embolization (TACE) and SBRT for
unresectable HCC.

Inclusion Criteria

Inclusion -

- Liver tumors treatable by SBRT not to exceed 10cm in greatest axial dimension.

- 800 cc of uninvolved liver

- Patients may have additional hepatic lesions if they are <3cm and can be treated
with TACE or RFA.

- Age > 18 years old

- Albumin > 2.4 g/dL.

- Total bilirubin < 3 mg/dL.

- INR ≤ 1.5.

- Creatinine < 2.0 mg/dL.

- Confirmed hepatocellular carcinoma by one of the following:

- Histopathology

- Two radiographic techniques (out of US, MRI, CT, Angiography) that confirm a
lesion >2 cm with arterial hypervascularization

- One radiographic technique that confirms a lesion >2 cm with arterial
hypervascularization and an elevated AFP

- Hepatic lesion in patients for whom surgical resection is not possible or would not
result in an opportunity for cure

- Tumor(s) <10cm

- Eastern Clinical Oncology Group performance status 0, 1 or 2

- No prior surgery, chemotherapy, or radiation for the current tumor

- Patients placed on the liver transplant registry are eligible for this trial, but
will be withdrawn from the protocol if they receive liver transplantation.

- TACE done prior to study enrollment is allowed if there were no more than 3
procedures within an 18 week period and SBRT can begin within 12 weeks of the last
TACE procedure.

Exclusion -

- Prior radiotherapy to the upper abdomen

- Prior TACE, RFA, or liver transplant

- Tumor(s) ≥ 10cm

- Large esophageal varices without band ligation

- Active GI bleed or within 2 weeks of study enrollment

- Ascites refractory to medical therapy

- Contraindication to receiving radiotherapy

- Women who are pregnant

- Administration of any systemic cytotoxic agents within the last 12 months

- Presence of extrahepatic metastases

- Participation in another concurrent treatment protocol

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:

To establish the efficacy and toxicity of TACE combined with SBRT.

Outcome Time Frame:

Every year

Safety Issue:


Principal Investigator

Daniel T Chang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

December 2014

Related Keywords:

  • Carcinoma, Hepatocellular
  • Hepatobiliary Neoplasm
  • Liver Carcinoma
  • Neoplasms
  • Carcinoma
  • Carcinoma, Hepatocellular



Stanford University School of Medicine Stanford, California  94305-5317