Unresectable or metastatic renal cell carcinoma
Conditions
Interventions
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
Sponsors
Department of Radiology, University of Yamanashi
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1)Active double cancer(except for some early or cured cancer as followe:carcinoma in situ, mucosal cancer, stage I prostate, breast, or laryngeal cancer) 2)Serious heart disease,uncontrolled diabetes mellitus despite continuing treatment of insulin,cardiac infarction within 6 months before enrollment,uncontrolled hypertension,history of severe infections,watery diarrhea,paresis of intestine,ileus,autoimmune disease,other severe complications 3)Radiographically (chest X-P or CT image) confirmed interstitial pneumonitis or pulmonary fibrosis 4)Severe emphysema, chronic bronchitis, asthma 5)Continuous systemic administration of steroid 6)Severe mental illness 7)women who are or may be pregnant or in lactatoin 8)Unsuitable patients judged by the attending physician or radiation-oncologist(previous irradiation is ignored) 9)A history of pretreatment within 28 days before the start of first Nivolumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of non-irradiated lesion at 24 weeks after the starting of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKan Marino
Faculty of Medicine,University of Yamanashi Department of radiology
Outcome results
None listed