Phase 2
N=20
Sorafenib Therapy Prior to Radiofrequency Ablation for Intermediate Sized Hepatocellular Cancer
Hepatocellular Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00813293 ↗Enrolled (actual)
20
Serious AEs
10.5%
Results posted
Jun 2020
Primary outcome: Primary: Coagulation Zone Diameter-Short Axis — 36.0; 35.1 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sorafenib (Drug); radiofrequency ablation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coagulation Zone Diameter-Short Axis |
36.0; 35.1 | — |
| PRIMARY Coagulation Zone Diameter-Long Axis |
42.4; 44.1 | — |
| PRIMARY Coagulation Zone Volume |
30.7; 30.5 | .794 |
| SECONDARY Feasibility Rate |
90; 90 | — |
| SECONDARY Number of Treatment-Related Grade 1-4 Adverse Events (AEs) by Day 9 |
8; 4 | — |
| SECONDARY Number of Treatment-Related Grade 1-4 Adverse Events (AEs) on Day of Radiofrequency Ablation (RFA) |
5; 4 | — |
| SECONDARY Number of Treatment-Related Grade 1-4 Adverse Events (AEs) One Month After Radiofrequency Ablation (RFA) |
8; 4 | — |
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). Radiofrequency ablation has been used to treat many types of tumors, including hepatocellular cancers. During RFA 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. Pre-clinical data suggests that sorafenib may improve the efficacy of RFA.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00813293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.