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

Preoperative Criteria

• Renal local advanced renal cell carcinoma and be suitable to radical nephrectomy.
• Tumor >=7cm, the lymph nodes in metastasis can be resectable, the renal vein or inferior caval vein with metastatic thrombus can be resectable also, clinical staging>=T2anyNMo.
• Resectable tumor with multiple-lesion in ipsolateral kidney Enrolment Criteria
• No distant metastasis.
• Not undergoing any adjuvant or systematic anti-tumor therapy, such as chemotherapy, biotherapy or radiotherapy.
• After the nephrectomy 4-12 weeks and should be recovery in the postoperative complications.
• ECOG scores 0-1.
• Referring to the Scoring Algorithm to Predict Metastasis after Radical Nephrectomy in Patients with clear cell renal cell carcinoma, all the patients score higher than 6. Metastatic lymph node with clinical diagnosis have been resected, all the resected specimen edge be negative in pathological detection.

The pathological diagnosis of renal cell carcinoma:

• No remnant tumor with postoperative imaging screening with CT or MRI.

• The liver and renal function, hemocytogenesis function meet the below criteria within the 4 weeks before the enrollment.

  • Granulocytes count >1500/mm3
  • Blood platelet >100000/mm3
  • Creatinine\<2 times of the upper of the reference value
  • Total bilirubin\<1.5 times of the upper of the reference value
  • Alanine aminotransferase/aspartate aminotransferase\<2.5 times of the upper of the reference value
  • The informed consent has been endorsed.

Exclusion Criteria:

• Other coincident carcinoma, but not including carcinoma in situ of cervix and basal cell epithelioma after radical therapy and bladder carcinoma superficially(Ta,Tis,T1) or carcinoma having been cured 3 years ago.
• Cardiac dysrhythmia need agent intervention(not including β-receptor inhibitive or digoxin treatment), coronary heart disease, myocardial infarction occurred in the later 6 months, heart failure assessment higher than NYHA II
• Seriously active infection with bacteria or fungus
• HIV infection or HBV/HCV infection with IFN-a intervention.
• Dysfunction in blood coagulation.
• Epilepsia with drug treatment.
• Those cannot take tablets orally.
• Allogeneic organ transplantation.
• Drug abuse or concomitant conditions such as psychologically or socially factors which may intervene the assessment.
• Hypersensitiveness to the studying adjuvant or the trial-relevant drugs.
• Pregnancy or lactation, pregnancy test must be negative within the 14 days before the trial beginning, either females or males must be contraceptive during the trial.

• The following concomitant therapeutics must be excluded:

  • Anti-tumor agents, immunological or hormonal therapy
  • Radiotherapy
  • Biological therapeutics such as G-CSF or GM-CSF
  • Autologous bone marrow transplantation or stem cell treatment
  • The other trial medicine therapeutics
  • Bevacizumab treatment or other agents effected in VEGF or VEGF-receptor, such as inhibitive in Raf or MEK