A Multi-Center, Non-Controlled Clinical Study of Sorafenib Adjuvant Therapy in Advanced Renal-Cell Carcinoma
Status:
Unknown status
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
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,5
years.
The purpose of this study is:
- To study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate
in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy.
- To observe the incidence of hand-foot skin reaction (HFSR) after the Urea (10% or 5%)
based cream intervention treatment.
The primary end point is the disease-free survival(DFS).The secondary end point is overall
survival(OS),the drug safety and tolerance, the occurrence of hand foot skin reaction(HFSR)
at the week of 3,6,12,the skin toxicity(not include HFSR) higher than CTCAE(Common
Terminology Criteria for Adverse Events) Grade 2 at the 12th week, the incidence of HFSR
after the Urea (10% or 5%) based cream intervention treatment.
Phase:
Phase 2
Details
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborators:
Beijing University of Chinese Medicine Central South University Changhai Hospital China Medical University, China Fudan University Huazhong University of Science and Technology Jiangsu Province Centers for Disease Control and Prevention Peking Union Medical College Hospital Shanghai Jiao Tong University School of Medicine Sichuan University Tianjin Medical University Zhejiang University