immune checkpoint inhibitor related colitis
Conditions
Interventions
traditional group:glucocorticoid sequential biological agents
early combination group:glucocorticoid combined with biological agents
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)The ages of patients are between 18 to 75 years old. (2)They are confirmed solid tumor or hematological malignancy by pathology. (3)They use immune checkpoint inhibitors (ICIs) for the first time combined with or without chemotherapy. (4)The clinical diagnosis of irAE colitis is comfirmed. (5)The severity of cloitis is 3 grade or 4 grade.
Exclusion criteria
Exclusion criteria: (1)The patient is allergic to any component of vedolizumab or infliximabhe. (2)The patient has active infection including tuberculosis, septicemia, cytomegalovirus, EB virus, etc. (3)Neutrophil <2*109/L and/or Platelet<100*109/L. (4)The transaminase value of liver function is more than 80U/L with or without elevated bilirubin or the renal function is insufficiency or the patient has heart failure. (5)The patient has progressive multifocal leukoencephalopathy(PML).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treat to remission time; | — |
Secondary
| Measure | Time frame |
|---|---|
| total dose of glucocorticoid;times of failure of glucocorticoid reduction;recurrence rate of irAE colitis;Incidence of new occurrence irAE;progression-free survival,PFS;overall survival, OS;Incidence of drug infusion reaction of biological agents;Incidence of opportunity infection;Incidence of severe opportunity infection; | — |
Countries
China
Contacts
Public ContactWang Mengzhao
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed