A Prospective Study of HCV-RNA Kinetics During Treatment With Sorafenib in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C
If you agree to participate in this study, you will be asked to undergo some screening tests
or procedures to confirm that you are eligible. Many of these tests and procedures are
likely to be part of regular cancer care and may be done even if it turns out that you do
not take part in the research study. If you have had some of these tests or procedures
recently, they may or may not have to be repeated. These tests include: a medical history,
hepatitis C genotype test, performance status, tumor assessment, blood tests and a urine
test. If these tests show that you are eligible to participate in the research study, you
will begin the study treatment. If you do not meet the eligibility criteria, you will not be
able to participate in this research study.
If you take part in this research study, you will be given a sorafenib study drug-dosing
diary for each treatment cycle. Each treatment cycle lasts 28 days (4 weeks), during which
time you will be taking the study drug twice daily. The diary will also include special
instructions for sorafenib.
During all cycles you will have a physical exam and you will be asked questions about your
general health and specific questions about any problems that you might be having and any
medications you may be taking. Your blood pressure will be monitored on the day you receive
your first dose of sorafenib and then at weeks 2,4,6 and 8 during sorafenib treatment.
The following blood tests will be performed as part of the research study: HCV RNA
levels-about 2 tablespoons of blood will be drawn to check the levels of hepatitis C in your
blood (HCV RNA) to see if sorafenib is having an affect. These tests will be completed at
the following times: one week before you receive your first dose of sorafenib, at weeks
2,4,8 and 12 during sorafenib treatment, and then 2 weeks after your last dose. AFB
Biomarkers-about 2 tablespoons of blood will be drawn to test for a protein called alpha
fetoprotein (AFP), which the researchers use to measure how your body responds to treatment
(biomarker). These tests will be completed at the following times: at weeks, 2,4,8 and 12
during sorafenib treatment, and then 2 weeks after your last dose.
We will assess your tumor by CT or MRI scan once every 8 weeks.
After the final dose of study drug we will ask you to return to the clinic once every 2
weeks for the following procedures: Medical review, blood pressure, performance status and
research blood tests (HCV RNA and AFP). We would like to keep track of your medical
condition for the rest of your life. We would like to do this by calling you on the
telephone once a year to see how your are doing. Keeping in touch with you and checking your
condition every year helps us look at the long-term effects of the research study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in HCV-RNA level
Change in HCV-RNA level more than in 2 logs during treatment with sorafenib
Andrew Zhu, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|