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).
A total of 1500 patients with definitive diagnosis of malignant solid tumor or acute leukemia will be enrolled in this study. Patients are divided into 3 groups according to the anti-tumor therapy they are to receive. Three groups will be set up, namely group A: immunotherapy group (patients will be treated with immunotherapy, or immuno- plus targeted therapy, or immuno- plus chemotherapy); group B: targeted therapy group (patients will be treated with targeted monotherapy, targeted plus chemotherapy); group C: chemotherapy group (patients will be treated with chemotherapy). All patients received blood biochemistry and imaging at baseline, and adverse events were monitored. If a patient in the immunotherapy group presents with an AE, the AE is diagnosed by a multi-disciplinary MDT team including oncologists, rheumatologists, immunologists, respiratory pathologists, radiologists, and pathologists, and further diagnosed as irAE or non-irAE. All patients underwent hematologic testing every 3 days (at least 3 times) after the onset of AE including: blood routine examination, ferritin, CRP, D-dimer, and cytokines (IL-1β, IL-6, and TNF-α)until recovery from AE. Patients without AE will re-testing of baseline blood biochemistry every 4 treatment cycles.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,500
PD-1 inhibitor includes pembrolizumab,Nivolumab,Sintilimab,tislelizumab,Triplimab,Camrelizumab, Serplulimab. PD-L1 inhibitor includes durvalumab,Atezolizumab,Adebrelimab,Envafolimab.
Targeted drugs includes EGFR-TKIs,ALK-TKIs,Multitargeted Tyrosine Kinase Inhibitors, VEGF antibody, EGFR antibody, antibody-drug conjugates drugs
Chemotherapy drugs are determined based on the investigator's decision.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGcalculated cut-off value for serum ferritin in the diagnosis of irAE
Time frame: 1 year
Determining the sensitivity and specificity of serum ferritin in the diagnosis of irAE
Time frame: 1 year
Determining baseline level of serum ferritin predicts irAE occurrence
Time frame: 1 year
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