Advanced renal cell carcinoma
Conditions
Interventions
interferon-alpha administration sorafenib administration
Sponsors
Hokuriku Advanced Renal cell carcinoma Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age: 20 <=, 75 > 2.Patients with ECOG PS 0, 1 or 2 3.Histologically confirmed renal cell carcinoma 4.Patients with metastasis(M)+ or lymph node(N)+ 5.Patients with nephrectomy 6.Patients with no previous history of cytokine therapy, or molecularly targeted therapy.6) patients with at least 1 measurable lesion on CT, as defined by RECIST 7.Patients who are expected to survive at least 3 months 8.Patients who meet 1) through 9) of the following test and adequate functions of major organs 1) hemoglobin >= 9.0 g/dL 2) neutrophil count >= 1,500/microL 3) platelet>=100,000//microL 4) PT or PT-INR and APTT <= 1.5 times the maximum of the normal range of each institute 5) total bilirubin <= 1.5 times the maximum of the normal range of each institute 6) ALT and AST <= 2.5 times the maximum of the normal range of each institute ( <= 5 times the maximum of the normal range at the study site in patients with hepatic metastasis) 7) alkali phosphatase <= 4 times the maximum of the normal range of each institute 8) serum creatinine <= 2.0 times the maximum of the normal range of each institute 9) amylases and lipases <=2.0 times the maximum of the normal range of each institute 9. Patients with written, signed, dated, and witnessed informed consent prior to the study
Exclusion criteria
Exclusion criteria: 1.Patinets being treated with Shosaikoto 2.Patients with autoimmunehepatitis 3.Known hypersensitivity to interferon or Sorafenib 4.Known hypersensitivity to biologics, such as vaccines 5.Myocardial infarction within the previous 12 months 6.Severe arrhythmias 7.Active or symptomatic angina pectoris or coronary artery disease 8.Poorly controlled hypertension 9.Previous history of renal failure 10.Poorly controlled diabetes mellitus 11.Active acute or chronic infection or serious intercurrent illness 12.Liver cirrhosis 13.Intracranial metastasis 14.Interstitial pulmonary disease 15.Severe mental disorder, such as severe depression 16.Pregnant, or women who have a possibility of pregnancy 17.Investigator determines as unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan
Outcome results
None listed