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

Phase 2
18 Years
70 Years
Open (Enrolling)
Renal Cell Carcinoma

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Trial Information

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.

Inclusion Criteria:

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival

Outcome Time Frame:

November 2008-November 2013

Safety Issue:



United States: Food and Drug Administration

Study ID:

Bay 43-9006



Start Date:

November 2008

Completion Date:

November 2013

Related Keywords:

  • Renal Cell Carcinoma
  • sorafenib
  • renal cell carcinoma
  • disease free survival
  • Hand food skin reaction
  • Carcinoma
  • Carcinoma, Renal Cell