Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma

Inclusion Criteria:

* Histologically confirmed renal cell carcinoma (primary tumour or biopsy/surgery of metastases)
* Radiologically confirmed metastatic disease
* Surgically removed primary tumour so feasible (nephrectomy or nephron-sparing surgery as indicated)
* Karnofsky-Performance Status \>70%
* Age 19-75 years
* Life expectancy of at least 3 months
* Adequate bone marrow function (i.e. white blood cell count above 3000/μL, platelet count above 75 000 /μL, hemoglobin above 9 mg/dl)
* Adequate organ function (i.e. serum creatinine, bilirubin and AST below 1.25 x the upper limit of the institutions' normal range)
* Negative pregnancy test for female patients
* Written informed consent

Exclusion Criteria:

* Age \<19 or \>75 years
* Karnofsky-Performance Status \< 70%
* Untreated or uncontrolled brain metastases
* Second neoplasia
* Primary tumour surgically removable
* Solitary, surgically removable metastases
* Major concomitant diseases of the cardiovascular, respiratory or renal systems, as well as active systemic infections
* Severe renal disease or liver insufficiency or myeloid dysfunction (including patients with a history of a disease that is likely to interfere with the metabolism or excretion of the test medication)
* Other less common diseases as peptic ulcer disease, inflammatory bowel disease, autoimmune disease (severe known psoriasis, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.)
* Drug addiction (including excessive alcohol consumption) within 1 year prior to study start.
* History of other conditions consistent with decompensated liver disease or other evidence of bleeding form esophageal varices.
* History of chronic hepatitis and immunsupressiva
* Known HIV Infection
* Evidence of allergy or hypersensitivity against recombinant Interferon alfa-2a or other components of preparation.
* History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.
* Seizure disorders and /or compromised central nervous system function.
* History of evidence of severe retinopathy
* Patient unwilling or unable to give informed consent
* Pregnancy or breastfeeding