NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180024

Registered date:09/10/2018

NIVOIGERCC

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUnresectable or metastatic renal cell carcinoma
Date of first enrollment10/05/2018
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Arm1 Patients receive 12cycles biweekly Nivolumab in total Arm2 Patients receive 12cycles biweekly Nivolumab in total and receive IGE at the third cycle of Nivolumab

Outcome(s)

Primary OutcomeResponse rate of non-irradiated lesion at the end of 12 cycles after the starting of the treatment.
Secondary Outcome1,Reduction rate of non-irradiated lesion at the end of 12 cycles 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. 5,Deduction of the serum IAP level at the end of 12 cycles, for those IAP positive patients(Measurable facility only)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaPrimary 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: The primary molecular-targeted agent has been finished, no another option of chemotherapy, Intermediate/poor risk: After the initial treatment, no suitable another molecular-targeted agent,or difficult to treat by nivo+ipi combination. 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 2 cycles, 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 criteriaPrimary 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

Contact

Public contact
Name Kan Marino
Address 1110, Shimokato, Chuo-shi, Yamanashi Yamanashi Japan 409-3898
Telephone +81-55-273-1111
E-mail marino@yamanashi.ac.jp
Affiliation University of Yamanashi Hospital
Scientific contact
Name Hiroshi Onishi
Address 1110, Shimokato, Chuo-shi, Yamanashi Yamanashi Japan 409-3898
Telephone +81-55-273-1111
E-mail honishi@yamanashi.ac.jp
Affiliation University of Yamanashi Hospital