Primary endpoint
To compare overall survival in CreaVax-RCC Inj and Sorafenib Groups.
Secondary endpoint
To assess renal cell carcinoma patients including safety, progression free survival, tumor suppression effect, response rate and immune response.

Treatment

1. CreaVax-RCC Inj.
primary vaccination
after two weeks interval, 4 times 
wash out: during 6 weeks
second vaccination (boosting)
after two weeks interval, 2 times
vaccination dose: CreaVax-RCC Inj 5 X 10^7Cell/injection

2. Sorafenib
be treated with 400mg oral sorafenib twice a day 

Arm Label

Target Number of Participant

Arm Type

Arm Description

Dosage : 50million cells/injection
Duration : 4 times every two weeks/ wash out: 6 weeks/ 2 times every 2 weeks / total 6 times injections

Arm Label

Target Number of Participant

Arm Type

Arm Description

Dosage : 400mg oral sorafenib twice a day 
Duration : primary oral   : 4 cycle ( 1 cycle = 6 weeks)
           secondary oral : 4 cycle ( 1 cycle = 8 weeks)
total 56 weeks

Gender

Age

Description

1. A patient have diagosed with metastatic renal cell carcinoma,have measurable metastatic lesion and agree to have Nephrectomy. 
2. Age≥18 years old / both male and female
3. A patient with ECOG scale(ECOG-PS) 0-2
4. A patient over 6 months survival expected
5. Hemoglobin≥ 9g/dL, WBC ≥ 4,000/mm3, Platelet ≥ 100,000/ mm3
6. PT(INR)<1.5, aPTT<1.5 X ULN
7. Creatinine≤ 2.0 mg/dL
8. Bilirubin ≤ 2.0 mg/dL, AST/ALT ≤ 100 IU/L
9. anti-nuclear antibody, anti-thyroglobulin  antibody negative 
10.A patient represent DTH positive about PPD(recall antigen)
11.A patient had not surgery, radiotherapy, hormone therapy, immune therapy or chemical therapy before screening for more than 4 weeks. In addition, patients have recovered from side effects.
12.A patient agreed to contracept during clinical study 
13.A patient participates in the clinical trial voluntarily signing up.  

1. A patient with another cancer or the history of cancer.
2. A patient with brain metastases
3. A patient with the medical history of autoimmune disease
4. A patient have a infectious disease needed to inject a parenteral antibiotic treatment.
5. A HBsAg, Anti-HCV, HIV positive patient
6. Patients is with myocardial infarction, congestive heart failure, serious cardiac disorder or unregulating high blood pressure.
7. A patient with obstructive, restrictive lung disease
8. Blood calcium level of patient is over 10.5mg/dL or having hypercalcemia
9. A patient with serious an internal disease
10.A patient have a hypersensitivity about Sorafenib or autologous cell vaccine
11.Pregnant woman, nursing woman
12.A patient with the medical history of psychological disease or epilepsy
13.A patient who has participated in another clinical trial within the last 4 weeks of the start of study
14.Patient is judged by the P.I as the patient is not suitable for the research.
<Medication record / treatment record>
1. Patients who have received the administration of an steroid, cyclosporin A or azathiopurine≤4 weeks prior to starting study treatment

1. Adequate tumor cells weren't stored and unavailable to produce for a minimum of vaccine preparations. 
2. Adequate PBMCs from leukapheresis weren't stored and unavailable to produce for a minimum of vaccine preparations.

Overall survival Response rate(CR+PR) 

four years later randomization

Progression Free Survival

four years later randomization

Suppression effect of tumor progression(CR+PR+SD)

four years later randomization

response rate

four years later randomization

cell proliferation response

four years later randomization

correlation of immune suppression agent's concentration and immune response induction

four years later randomization

Adverse event

four years later randomization

Vital sign

four years later randomization

physical examination

four years later randomization

laboratory test

four years later randomization