Status:
COMPLETED
Sorafenib Therapy Prior to Radiofrequency Ablation for Intermediate Sized Hepatocellular Cancer
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Hepatocellular Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to determine if sorafenib improves the effectiveness of a procedure called radiofrequency ablation (RFA) for the treatment of hepatocellular cancer (HCC). Radiofr...
Detailed Description
Hepatocellular cancer (HCC) has a poor prognosis with increasing mortality in the United States. Because HCC generally develops in patients with underlying liver disease, resection is often not possib...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00813293
Start Date
June 1 2009
End Date
November 1 2013
Last Update
June 13 2023
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215