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Randomized, Double-Blind, Placebo-Controlled, Phase II Trial Of Short Course Sorafenib Therapy Prior to Radiofrequency Ablation for Intermediate Sized (3.5 to 7cm) Hepatocellular Cancer

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Cancer

Thank you

Trial Information

Randomized, Double-Blind, Placebo-Controlled, Phase II Trial Of Short Course Sorafenib Therapy Prior to Radiofrequency Ablation for Intermediate Sized (3.5 to 7cm) Hepatocellular Cancer

Participants will be randomized to receive either sorafenib or placebo (pills with no
medication). Participants will take sorafenib or placebo on Days 1-9. Radiofrequency
ablation will be performed by an interventional radiologists on Day 10.

On Days 1 and 9 of the study participants will have a physical exam and blood tests
performed. A study MRI will be performed at Beth Israel Deaconess Medical Center (BIDMC)
prior to starting study medication and on Day 9. A tumor biopsy will be obtained at the time
of RFA. A CT scan will be performed after RFA.

Inclusion Criteria:

- Confirmed hepatocellular cancer (HCC) by pathology or by NCCN imaging guidelines

- All HCC stages are allowed. May be a liver transplant candidate.

- At least one tumor (index tumor) accurately measured as 3.5-7cm in diameter (long and
short axis diameter to be recorded, but only one needs to meet this criteria) on
baseline imaging.

- No prior therapy for the index tumor

- No prior systemic treatment for HCC within 4 weeks and no prior anti-VEGF therapy
within 8 weeks of study entry.

- Life expectancy > 8 weeks.

- ECOG >=0 or 1

- RFA clinically indicated for index tumor.

- Acceptable overall RFA and anesthesia risk.

- Adequate bone marrow, liver and renal function: Hemoglobin >9.0 g/dl; Absolute
neutrophil count (ANC)>1,500/mm3; Platelet count correctable to >50,000/mm3;
compensated liver function (Child-Turcotte-Pugh A, B7 or B8); Creatinine <1.5 times
ULN; INR correctable to <1.5.

- Ability to take oral medication and no evidence of impaired absorption.

Exclusion Criteria

- Urgent treatment of the index tumor anticipated.

- Participants who have not recovered from adverse events due to agents administered
more than 4 weeks earlier. Participants currently receiving any other study agents.

- Known brain metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to sorafenib.

- Participants receiving medications or substances that are inducers of CYP3A4
(rifampicin, St. John's wort, phenytoin, carbamazepine, phenobarbital and
dexamethasone) or that are metabolized/eliminated by predominantly UGT1A1 pathway or
by CYP2B6 and CYP2C8.

- Decompensated liver disease

- Uncontrolled hypertension

- Thrombolic or embolic events within the past 6 months.

- Hemorrhage/bleeding event within 4 weeks

- Serious non-healing wound, ulcer, or bone fracture.

- Evidence of severe or uncorrectable bleeding diathesis or coagulopathy

- Major surgery, open biopsy or significant traumatic injury within 4 weeks of study

- Contraindication to or inability to undergo the RFA procedure,

- Contraindication to or inability to undergo imaging with MRI

- Uncontrolled intercurrent illness

- Individuals with a history of a different malignancy unless disease-free for at least
5 years and are deemed by the Investigator to be at low risk for recurrence.
Individuals with the following cancers are eligible if diagnosed and treated within
the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma
of the skin.

- HIV-positive individuals on combination antiretroviral therapy

For additional inclusion/exclusion criteria details contact Study Site.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To prospectively investigate if sorafenib increases the effectiveness of RFA.

Outcome Description:

Difference in volume and diameter of coagulation zone

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Rebecca A Miksad, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

December 2013

Related Keywords:

  • Hepatocellular Cancer
  • Hepatocellular Cancer
  • HCC
  • Liver Cancer
  • radiofrequency ablation
  • RFA
  • sorafenib
  • nexavaar
  • liver directed therapy
  • interventional radiology
  • Liver Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115