This study evaluates the safety and efficacy of administering sorafenib concurrent with yttrium-90 radioembolization to patients with advanced hepatocellular cancer.
Studies in Asia of unresectable hepatocellular cancer (HCC) demonstrated that sorafenib could be administered safely at 400mg twice a day (BID) when initiated 14 days following radioembolization (RE). However, the ideal sequence of RE and sorafenib may not be completely elucidated, the two treatments given concurrently may be more effective than the sequential approach studied in the Asian trials. Preclinical models have demonstrated that sorafenib acts synergistically with radiation, increasing apoptosis. Furthermore, case reports suggest profound responses in patients who have received sorafenib concurrent with transarterial radioembolizatoin (TARE) as evidenced by improvement in symptoms, \>80% decrease in alpha fetoprotein (AFP), and conversion from unresectable to resectable. Sorafenib concurrent with TARE may take advantage of the synergistic relationship between the two therapies and prove to be a more effective treatment strategy than sequential administration of TARE and sorafenib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Sorafenib 400mg PO BID for Cohort 1, if 2 or more patients with dose-limiting toxicity toxicity (DLT), Chort -1 is sorafenib 200mg PO BID, if 2 or more patients with DLT, sorafenib 200mg PO daily
Yttrium-90 SIR-Spheres microspheres are instilled through a catheter into a branch of the hepatic artery
University of Hawaii
Honolulu, Hawaii, United States
Safety and tolerability of concurrent sorafenib and yttrium-90 transarterial radioembolization (TARE) for patients with advanced hepatocellular cancer as measures by Adverse events
All patients will be monitored and evaluated for clinical toxicities during the treatment period and queried at each follow-up visit for Adverse Events (AEs). Patients may volunteer information concerning AEs. All AEs will be graded by using the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
Time frame: 2 months
Efficacy of concurrent sorafenib and yttrium-90 transarterial radioembolization (TARE) for patients with advanced hepatocellular cancer as measured by response rate, time to progression (TTP), progression free survival (PFS), overall survival (OS)
Response: Response will be evaluated by contrast enhanced MRI or CT and response rates will be reported separately as measured by RECIST and mRECIST criteria. Duration of response will also be measured according to RECIST and mRECIST guidelines. Survival: The time to progression, progression free survival, and overall survival will be measured. TTP and PFS will be calculated based on progression as defined by RECIST and mRECIST and both intervals will be reported.
Time frame: 1 year
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