Exploratory study of the efficacy and safety of salazosulfapyridine for immune checkpoint inhibitor related colitis - iRECSA study

Yamada Takeshi0 个研究点目标入组 10 人开始时间: 2021年11月19日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Diarrhea or bloody stool lasting more than 1 week during immune checkpoint inhibitor (ICI) administration or within 3 months of discontinuation
•2) Mayo score 3-10 points and Mayo endoscopic subscore 1 point or higher
•3) Age more than 20 years
•4) Eastern Cooperative Oncology Group performance status 0-2
•5) Written informed consent was obtained from patient after providing a detailed explanation of the clinical study prior to registration

•1) Colonoscopic findings clearly indicate that the cause is another disease
•2) A history of inflammatory bowel disease
•3) Concomitant use of prohibited drugs
•4) Using or planning to use steroids during 1 week before registration or 2 weeks after registration
•5) Complicated or suspected toxic megacolon or gastrointestinal perforation
•6) Complications of other poorly controlled irAEs at the time of registration
•7) Severe liver disease (AST or ALT >100 IU/L)
•8) Severe kidney disease (serum creatinine >2 mg/dl)
•9) History of hypersensitivity to sulfa drugs or salicylic acid products
•10) Poorly controlled bronchial asthma (rpeated asthma attacks within a month)
•11) Pegnant or may become pregnant female
•12) Lctating female
•13) Participation in the clinical trial is determined as unsuitable

发起方

Yamada Takeshi