NIVOIGERCC

JRCT ID: jRCTs031180024

Registered date:09/10/2018

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable or metastatic renal cell carcinoma
• Date of first enrollment: 10/05/2018
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Arm1 Patients receive Nivolumab every 4 weeks for 6 cycles in total
Arm2 Patients receive Nivolumab every 4 weeks for 6 cycles in total and receive IGE at the second cycle of Nivolumab

Outcome(s)

• Primary Outcome: Response rate of non-irradiated lesion at the end of treatment.
• Secondary Outcome: 1,Reduction rate of non-irradiated lesion at the end of treatment 2,Overall survival rate at 2-year 3,Cause-specific survival rate at 2-year 4,Incidence of interstitial pneumonitis (Grade 2 or more), acute kidney injury (Grade 4 or more), other fatal toxicities (Grade 3 or more),at NCI-CTCAE v4.0.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Primary registration
1)Cytologically or histologically confirmed renal cell carcinoma.or clinically judged as renal cell carcinoma. 2)At least two measurable lesions excluding only lung lesions. 3)Radical operation not applicable 4)Favorable risk: Treatment is either cancelled or complete after the initial treatment; no other prioritized chemotherapy can be applied; any applicable chemotherapy is rejected. Intermediate/poor risk: No other prioritized chemotherapy can be applied after the initial treatment; suitable chemotherapy is not applicable for some reason; suitable chemotherapy is rejected by the patient. 5)Immediate Radiotherapy not applicable 6)Men and women 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=2000 per uL or more,2.Hb=9.0g per dL or more, 3.PLT=50000 per uL or more, 4.Serum Creatinine=3.0mg 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
Secondary registration
Among the primary registered patients with completion of initial treatment protocol, at the evaluation just before the second registration after the first cycle, no observation of interstitial pneumonitis (Grade 2 or more), acute kidney injury (Grade 4 or more), or other fatal toxicities (Grade 3 or more) , according to the NCI-CTCAE v4.0.

Exclude criteria

Primary regisration
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 7 days before the start of first Nivolumab
Secondary registration
1) Tumor progression, or decreasing of the ECOG performance status less than 3
2) Principal Investigator will end the protocol, when tumor progression, or significant fatal or life-threatening toxicities were observed.
3) Disappearance of the irradiation site.

Related Information

• Primary Sponsor: Onishi Hiroshi
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.,Bristol-Myers Squibb K.K.
• Secondary ID(s): UMIN000030972