This is a prospective, multicenter observational study to explore the predictive factors of checkpoint inhibitor pneumonitis (CIP) and to establish predictive models by combining imaging information for IRP. The imaging type of CIP, the pathological type, various inflammatory cytokines and tumor proportion score(TPS) of PD-L1 expression level, etc. will be paid more attention.
Prospective dual-arm, multicenter observational study to explore the predictive factors of checkpoint inhibitor pneumonitis (CIP) and to establish predictive models by combining imaging information.Patients will receive work-up, treatment and follow-up exclusively as routinely done except monitoring and evaluation of CIP. Necessary tests will be required, such as lung function tests, lymphocyte subsets, and thin-section CT of the chest during evaluation of the disease.This study mainly included patients with malignant tumor who received immune checkpoint inhibitors for the first time.Fasting venous blood was taken before treatment and before cycle 3,5...2n+1 of treatment. Then the blood samples were centrifuged and frozen in a refrigerator at -80℃ for later mass spectrometry analysis. IrAEs of patients was strictly recorded according to CommonTerminology Criteria Adverse Events V4.0 (CTCAE V4.0). The main objective was to explore the relationship between various indicators and the occurrence of CIP, including pulmonary ventilation and diffusion function at baseline, C-reative protein(CRP), cytokines, interleukin-6(IL-6), CD4+ T lymphocyte count and percentage, CD8+ T lymphocyte count and percentage, NK cell count and percentage, total T lymphocyte count and percentage, neutrophil counts and percentages, eosinophilic cell count and percentage, white blood cell count, blood platelet count, serum albumin(ALB), alanine aminotransferase(ALT), aspartate aminotransferase (AST), γ-glutamyl transpeptadase（γ-GGT), body mass index (BMI), serum procalcitonin(PCT), smoking index and various inflammatory cytokines. Primary study endpoints: The predictive factors and the predictive models of CIP. Secondary study endpoints: The incidence and clinical characteristics of CIP.
Study Type
OBSERVATIONAL
Enrollment
440
Patients with malignant tumors who first received ICIs
The change of C reactive protein(CRP); mg/L
CRP level in the serum.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Interleukin-6(IL-6); Pg/ml
IL-6 level in the serum.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
CD4+ T lymphocyte; /uL
The absolute and relative counts of CD4+ T lymphocyte in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
CD4+ T lymphocyte; percent
Percentage of CD4+ T lymphocyte in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
CD8+ T lymphocyte; /uL
The absolute and relative counts of CD8+ T lymphocyte in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
CD8+ T lymphocyte; percent
Percentage of CD8+ T lymphocyte in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
NK cell; /uL
The absolute and relative counts of NK cell in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
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NK cell; percent
Percentage of NK cell in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
White blood cell count; 10^9/L
The white blood cell count in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Lymphocyte count; 10^9/L
The absolute and relative counts of total lymphocyte count in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Lymphocyte count; percent
Percentage of total lymphocyte count in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Eosinophils count; 10^9/L
The absolute and relative counts of eosinophils count in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Eosinophils count; percent
Percentage of eosinophils count in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Blood platelet count; 10^9/L
The blood platelet count in whole blood.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Alanine aminotransferase(ALT); U/L
The ALT level in the serum.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Aspartate aminotransferase (AST); U/L
The AST level in the serum.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Serum albumin; g/L
The albumin level in the serum.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
γ-glutamyl transpeptadase（γ-GGT); U/L
The γ-GGT level in the serum.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Smoking index
The average root number per day multiplied by smoking years of smoking, that is, smoking index.
Time frame: At baseline
Body mass index (BMI); kg/m^2
The body's weight(Kg) divided by the square of your height(m), that is, body mass index.
Time frame: At baseline
Serum procalcitonin(PCT); ng/ml
The PCT level in the serum.
Time frame: Before Cycle 1,3, 5, 7 and 2n+1(each cycle is 21 days) and through study completion, an average of 6 months.
Forced vital capacity(FVC); L
The maximum amount of air that can be exhaled as soon as possible after the maximum inhalation. FVC was used to evaluate pulmonary ventilation function.
Time frame: Before Cycle 1.
Forced the first second of expiratory volume (FEV1); L
the first second of exhalation during the maximum exhalation after the maximum deep inhalation. FEV1 was used to evaluate pulmonary ventilation function.
Time frame: Before Cycle 1.
FEV1/FVC; percent
FEV1 accounts for the percentage of FVC. FEV1/FVC was used to evaluate pulmonary ventilation function.
Time frame: Before Cycle 1.
Maximal mid-expiratory flow(MMEF); L/s
The average flow rate with forced exhalation of 25% to 75% of lung capacity. FEV1/FVC was used to evaluate pulmonary ventilation function.
Time frame: Before Cycle 1.
Fractional exhaled nitric oxide (FeNO) measurement；ppb
FeNO measurement quantified the amount of nitric oxide (NO) in one's exhaled breath, which was used to evaluate pulmonary diffusion function.
Time frame: Before Cycle 1.
The incidence of IRP; percent
The incidence of IRP in the general population receiving ICIs
Time frame: Up to 36 months