immune checkpoint inhibitor related colitis immune checkpoint inhibitor related colitis
Conditions
Interventions
salazosulfapyridine (1000mg) given on 4 times daily for 14 days
salazosulfapyridine
Sponsors
Yamada Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with improved clinical score (difference in partial Mayo score is 1 point or more, or partial Mayo score is less than 1) after 2 weeks of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with improved endoscopy score (UCEIS difference is more than 2 point) after 8-12 weeks of administration Percentage of patients with improved clinical score (Mayo score difference is more than 1 point) after 8-12 weeks of administration CTCAE grade before, 2 weeks after, and 8-12 weeks after initiation of treatment Percentage of patients with improved clinical score (SCCAI difference is more than 1.5 point, Lichtiger index difference is more than 3 point) after 2 weeks and 8-12 weeks of administration Percentage improvement in colonic histopathology after 8-12 weeks of administration Changes in CRP, LRG and ESR (1 hr), before administration, 2 weeks after administration and 8-12 weeks of administration Relationship between morphological features of histopathological images and effects Changes in the number of apoptotic cells Adverse events associated with SASP Description of post-treatment and percentage of transition to steroid treatment Analysis of factors associated with the effects of SASP (Patient background, type of ICI and duration since ICI initiation, medication adherence, Mayo score at enrollment, endoscopy score at enrollment, histopathology) Exploratory evaluation of the relationship between changes in epithelial cell differentiation marker | — |
Contacts
Public ContactMariko Kobayashi
Tsukuba University Hospital
Outcome results
None listed