Sorafenib Concurrent With Yttrium-90 Transarterial Radioembolization in Patients With Advanced Hepatocellular Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02288507|
Recruitment Status : Withdrawn (Closed due to no accrual)
First Posted : November 11, 2014
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Cancer||Drug: Sorafenib Radiation: yttrium-90 radioembolization||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Sorafenib Concurrent With Yttrium-90 Transarterial Radioembolization in Patients With Advanced Hepatocellular Cancer|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: sorafenib & Yttrium-90 radioembolization
Sorafenib dose de-escalation starting at 400mg PO BID starting on Day1 Yttrium-90 radioemoblization on Day 14
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
Radiation: yttrium-90 radioembolization
Yttrium-90 SIR-Spheres microspheres are instilled through a catheter into a branch of the hepatic artery
Other Name: SIR-Spheres microspheres
- Safety and tolerability of concurrent sorafenib and yttrium-90 transarterial radioembolization (TARE) for patients with advanced hepatocellular cancer as measures by Adverse events [ Time Frame: 2 months ]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).
- 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) [ Time Frame: 1 year ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288507
|United States, Hawaii|
|University of Hawaii|
|Honolulu, Hawaii, United States, 96813|
|Principal Investigator:||Jared Acoba, MD||University of Hawaii|