A Multi-Center, Non-Controlled Clinical Study of Sorafenib Adjuvant Therapy in Locally Advanced Renal-Cell Carcinoma After Radical Nephrectomy
A one-arm, open, multi-center study, to evaluate sorafenib (400mg twice daily) as a adjuvant
to prevent recurrence of RCC(renal cell carcinoma) patients after radical nephrectomy with a
high-risk of recurring. To observe disease-free survival and the survival rate in 3 years,
and 5 years. To observe the incidence of hand-foot skin reaction (HFSR) after the Urea (10%
or 5%) based cream intervention treatment. 140 subjects are prospected to enter the trial.
The sorafenib adjuvant therapy is unremitting with a time of 12 months. For a convenient
record, every 6 weeks is regarded as a single observational cycle. The end-point are
recurrence, not being tolerant to the toxicity, need to stop the intervening study or
withdrawing the informed consent. It is necessary to evaluate the efficacy and safety every
6 weeks. At the screening stage and every 12 weeks imaging review are performed such as
abdominal and chest CT or MRI, the imaging methods of a single subject should be in
uniformity during the trial.
The post-treatment evaluation are performed 30 days after the last usage of the adjuvant in
order to collect all the adverse events (AE) and the survival rates of all the subjects. The
agent-relevant AE (known or unknown) should be reported to the drug safety institution, the
patients should be visited until the events solved, except the events can not be solved for
the subjects' underlying diseases.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
disease free survival
November 2008-November 2013
United States: Food and Drug Administration