immune-related adverse events
Conditions
Interventions
Control group:Based on clinical evaluation, physical examination, laboratory tests, and imaging findings, clinicians determine whether the etiology of a patients organ dysfunction is immune-related ad
Intervention Group:On the foundation of standard therapeutic protocols, novel biomarkers—informed by previously established multi-omics models of organ dysfunction from external cohorts—are assayed an
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Hospitalized patients; 3. Diagnosed with malignant tumor and receiving immunotherapy; 4. According to the standards of the Chinese Society of Clinical Oncology (CSCO), at least one newly developed organ injury of grade 2 or higher during this hospitalization compared to the previous visit; 5. Patients or their family members consent to and can cooperate with this study, voluntarily signing the corresponding informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Currently participating in other drug clinical trials; 3. The cause of the current organ dysfunction is definitively diagnosed as related to tumor progression; 4. Refusal to undergo multi-omics testing, explicitly declining enrollment, or unwillingness to cooperate with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sequential Organ Failure Assessment, SOFA; | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-day survival;90-day survival;Total Hospital Stay (days);ICU Length of Stay (LOS), days;Duration of Mechanical Ventilation (hours);Adverse events during hospitalization were monitored in two categories: 1) those related to antibiotic therapy (encompassing liver/kidney injury, opportunistic infections, etc.), and 2) those related to discontinuation of Immune Checkpoint Inhibitors (ICIs) (including tumor hyperprogression, autoimmune reactions, etc.).; | — |
Countries
China
Contacts
Public ContactWang Xiaoting
Peking Union Medical College Hospital
Outcome results
None listed