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

JRCT ID: jRCTs031210429

Registered date:19/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: immune checkpoint inhibitor related colitis
• Date of first enrollment: 11/04/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): salazosulfapyridine (1000mg) given on 4 times daily for 14 days

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yamada Takeshi