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Precision Intervention Strategies to Balance Antitumor Efficacy and Immune Toxicity Control in Immune Checkpoint Inhibitor-Related Colitis

Precision Intervention Strategies to Balance Antitumor Efficacy and Immune Toxicity Control in Immune Checkpoint Inhibitor-Related Colitis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121669
Enrollment
Unknown
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune checkpoint inhibitor-related colitis

Interventions

irAE-controlled & efficacy-maintained group:None
irAE-controlled & efficacy-reduced group:None

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 18–75 years; 2.Patients treated with ICIs and diagnosed with >= grade 2 immune-related adverse event (irAE) colitis, according to clinical indications, with glucocorticoids (prednisone or methylprednisolone at 1–2 mg/kg/day) or biologic agents (infliximab or vedolizumab), in accordance with the National Comprehensive Cancer Network (NCCN) guidelines and the Chinese Society of Clinical Oncology (CSCO) consensus;

Exclusion criteria

Exclusion criteria: 1.Patients with inflammatory bowel disease, gastrointestinal infections, or recent use of antibiotics or probiotics;

Design outcomes

Primary

MeasureTime frame
Antitumor efficacy of Immune Checkpoint Inhibitors (ICIs);—

Countries

China

Contacts

Public ContactTan Bei

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

tanbei0626@aliyun.com+86 10 6915 5017

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026