| NCT ID | NCT06702566 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Immune-related Adverse Event |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2024-07-04 |
| Primary Completion | 2026-07-16 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a prospective clinical study to clarify serum ferritin as a biomarker for the diagnosis, differential diagnosis and prognosis of immune-related adverse event(irAE).
Eligibility Criteria
Inclusion Criteria: Only patient who meet all the following conditions can be selected for this trial: 1. Patients voluntarily sign informed consent; 2. The age was 18-75 years old, and the gender was not limited; 3. Patients with definitive diagnosis of malignant solid tumor or acute leukemia; 4. Patients enrolled in will be treated with immunotherapy (including immuno- monotherapy，or immuno- plus targeted therapy, or immuno- plus chemotherapy), or targeted therapy (including targeted monotherapy, or targeted plus chemotherapy), or chemotherapy. 5. The Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 or 2 for physical fitness; 6. Sufficient bone marrow reserve at screening, defined as: * Neutrophil absolute value (ANC) \> 1.5 × 10\^9/L； * Lymphocyte absolute value (ALC) ≥ 0.3 × 10\^9/L； * Platelet (PLT) ≥ 100 × 10\^9/L； * Hemoglobin (HGB) ≥ 100g / L; 7. The screening has appropriate organ function and meets the following criteria: * Aspartate aminotransferase (AST) ≤ 2.5 times