Sorafenib and Yttrium-90 Glass Microspheres for Advanced Hepatocellular Carcinoma (HCC)
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|ClinicalTrials.gov Identifier: NCT01900002|
Recruitment Status : Active, not recruiting
First Posted : July 16, 2013
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: Sorafenib Radiation: Yttrium-90 Microspheres Behavioral: Follow-Up Phone Calls||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sorafenib and Yttrium-90 Glass Microspheres for Advanced Hepatocellular Carcinoma, BCLC Stage C|
|Actual Study Start Date :||September 13, 2013|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2020|
Experimental: Sorafenib and Yttrium-90
Starting dose of Sorafenib 400 mg 2 times a day starting on Day 1 of Cycle 1, 4 weeks before starting TheraSphere treatment. After 4 weeks Sorafenib therapy, Y-90 procedure performed. TheraSphere administered via infusion under imaging guidance through an hepatic arterial catheter appropriately positioned in the arterial anatomy to permit selective infusion of TheraSphere into the target tissue selected for treatment. The procedure should take about 1½ to 3 hours to complete.
Starting dose 400 mg by mouth 2 times a day starting on Day 1 of Cycle 1, 4 weeks before starting TheraSphere treatment
Other Names:Radiation: Yttrium-90 Microspheres
After 4 weeks (+/- 1 week) of sorafenib therapy, Y-90 procedure performed. TheraSphere is administered via infusion under imaging guidance through an hepatic arterial catheter appropriately positioned in the arterial anatomy to permit selective infusion of TheraSphere into the target tissue selected for treatment.Behavioral: Follow-Up Phone Calls
After completion of End-of-Treatment visit, study staff will contact participant by phone every 3 months. Each follow-up phone call should last about 15-30 minutes.
- Toxicity of Sorafenib and Yttrium-90 [ Time Frame: Start of treatment up to two 28-day cycles ]Toxicity is defined as any grade 3 or greater complications attributable to the treatment. Participants will be evaluated for toxicity every 4 weeks after start of study drug which may include the sorafenib treatment and Y-90 procedure since the Y-90 procedure may be performed (+/- 1 week) after start of sorafenib treatment.
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): NCT01900002
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ahmed Kaseb, MBBS||M.D. Anderson Cancer Center|