Multi-institutional randomized Phase 2 trial of a treatment of nivolumab combined with stereotactic body radiotherapy for patients with unresectable or metastatic renal cell carcinoma

INTERVENTION: Patients receive 12cycles bi‐weekly Nivolumab in total Patients receive 12cycles bi‐weekly Nivolumab in total and receive SBRT at the third cycle of Nivolumab CONDITION: Unresectable or metastatic renal cell carcinoma PRIMARY OUTCOME: Response rate of non‐irradiated lesion at 24 weeks after the starting of the treatment. SECONDARY OUTCOME: 1,Reduction rate of non‐irradiated lesion at 24weeks; 2,Overall survival rate at 2‐year; 3,Cause‐specific survival rate at 2‐year; 4,Occurrence rate of severe toxicities; 5,Decrease of serum IAP level at 24 weeks INCLUSION CRITERIA: 1)Cytologically or histologically confirmed renal cell carcinoma.or clinically judged as renal cell carcinoma. 2)At least two measurable lesions excluding lung lesion. 3)Radical operation not applicable 4)First‐line molecular targeted drugs was finished, no prior indication of the other drug or when patient refuses 5)Immediate Radiotherapy not applicable 6)Aged 20 or more 7)ECOG Performance status of 0‐2 8)Judgement by Radiation‐oncologist for indication and safely of irradiation 9)Satisfication of the following criteria in the latest labo data within 7 days of the registration:1.WBC=3000 per mm3 or more,2.Hb=9.0g per dl or more, 3.PLT=50000 per mm3 or more, 4.Serum Creatinine=2.0mg per dl or less and eGFR 30mL/min or more 5.Total bililubine=1.5mg per dl or less, 6.GOT(AST)=100IU per L or less, 7.GPT(ALT)=100IU per L or less, 8.SpO2=93% or more(room air) 10)Written informed consent after enough explanation