This trial is active, not recruiting.

Condition hepatocellular cancer
Treatments sorafenib, radiofrequency ablation
Phase phase 2
Sponsor Beth Israel Deaconess Medical Center
Collaborator Dana-Farber Cancer Institute
Start date January 2009
End date December 2016
Trial size 20 participants
Trial identifier NCT00813293, 08-256, IST000508, K23CA139005


The purpose of this research study is to determine if sorafenib improves the effectiveness of a procedure called radiofrequency ablation for the treatment of hepatocellular cancer. During radiofrequency ablation (RF ablation) a needle is inserted into the tumor tissue and heat is used to kill the tumor cells.

Sorafenib has been approved by the FDA for the treatment of hepatocellular cancer that cannot be treated with surgery. Radiofrequency ablation has been used to treat many types of tumors, including hepatocellular cancers. Pre-clinical data suggests that sorafenib may improve the efficacy of RFA. The use of sorafenib prior to RF ablation in this study is "investigational" and has not been approved by the FDA. "Investigational" means that this combination is still being studied and that research doctors are trying to find out more about it. In this study, the study doctors hope to better understand the extent to which the combination of sorafenib and RFA may be done practically and successfully. Correlative imaging and tumor studies will evaluate mechanisms of action as well as novel predictors of RFA efficacy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Sorafenib treatment given prior to RFA
sorafenib Nexavar
Short course of sorafenib given orally twice a day prior to RFA
radiofrequency ablation RFA
Radiofrequency ablation to tumor. Repeat sessions allowed for full tumor treatment.
(Placebo Comparator)
Placebo pills given prior to RFA
radiofrequency ablation RFA
Radiofrequency ablation to tumor. Repeat sessions allowed for full tumor treatment.

Primary Outcomes

To prospectively investigate if sorafenib increases the effectiveness of RFA.
time frame: 2 years
To prospectively describe the effects of sorafenib on RFA treatment parameters
time frame: 2 years

Secondary Outcomes

To describe the safety and feasibility of sorafenib prior to RFA.
time frame: 2 years
To explore the relationship between MRI and RFA effectiveness
time frame: 2 years
To investigate tumor tissue for changes after sorafenib and to assess for RFA predictors
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 entry. - 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.

Additional Information

Official title 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
Principal investigator Rebecca A Miksad, MD, MPH
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.