A Multi-Center, Non-Controlled Clinical Study of Sorafenib Adjuvant Therapy in Advanced Renal-Cell Carcinoma

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.

Conditions

• Renal Cell Carcinoma

Interventions

DRUG

sorafenib

sorafenib 400mg twice daily

Sponsors & Collaborators

• Beijing University of Chinese Medicine

  collaborator OTHER

• China Medical University, China

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Tianjin Medical University

  collaborator OTHER

• Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Jiangsu Province Centers for Disease Control and Prevention

  collaborator NETWORK

• Central South University

  collaborator OTHER

• Sichuan University

  collaborator OTHER

• Huazhong University of Science and Technology

  collaborator OTHER

• Chinese Academy of Medical Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2011-11-30

Completion

2013-11-30

Countries

• China

Study Locations