Exploration of the Predictive Marker and Establishment of Predictive Models of Checkpoint Inhibitor Pneumonitis

NCT04734067 | Unknown

• 1 other identifier: XJTU1AF2021LSK-001
• Study Type: observational
• Target: 440
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pneumonia, Interstitial

Keywords

immune checkpoint inhibitors; predictive marker; predictive model; immunotherapy

Outcome Measures

Primary Outcomes (26)

• The change of C reactive protein(CRP); mg/L

  CRP level in the serum.

  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.

  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.

  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.

  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.

  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.

  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.

  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; percent

  Percentage of NK cell in whole blood.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  At baseline

• Serum procalcitonin(PCT); ng/ml

  The PCT level in the serum.

  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.

  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.

  Before Cycle 1.

• FEV1/FVC; percent

  FEV1 accounts for the percentage of FVC. FEV1/FVC was used to evaluate pulmonary ventilation function.

  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.

  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.

  Before Cycle 1.

Secondary Outcomes (1)

• The incidence of IRP; percent

  Up to 36 months

Study Arms (1)

observational group

Patients receiving ICIs for the first time

Other: Immune checkpoint inhibitors(ICIs) therapy

Interventions

Immune checkpoint inhibitors(ICIs) therapy OTHER

Patients with malignant tumors who first received ICIs

observational group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant tumor receiving immune checkpoint inhibitors for the first time.

You may qualify if:

• age ≥ 18 years;
• Obtain written informed consent and any locally required authorization from the patient or his/her legal representative prior to the commencement of any study protocol related procedures, including screening assessments;
• Patients with malignant tumors confirmed by histology or cytology can be treated with ICIs after evaluation by a professional oncologist, with no restriction on cancer type or stage;
• Life expectancy on day 1 ≥12 weeks;
• When selected, the Eastern Cooperative Oncology Group (ECOG) physical status score was 0-2;
• No previous use of immunotherapy；
• No prior exposure to immune-mediated therapy;
• Have sufficient viscera function and bone marrow function;
• Evidence of postmenopausal status in women, or negative urine or serum pregnancy tests in premenopausal women.

You may not qualify if:

• The target lesion had received immune-related treatment or immune-mediated treatment before;
• Patients with clinically confirmed moderate to severe pulmonary interstitial fibrosis before taking ICIs;
• Major surgical procedures were performed within 28 days of the first medication;
• History of allograft transplantation;
• Active or previously documented autoimmune or inflammatory diseases or other contraindications for immunotherapy;
• Uncontrolled serious complications such as infection and acute cardio-cerebrovascular disease;
• The presence of another primary malignancy;
• anaphylaxis or hypersensitivity to immunotherapy or chemotherapy;
• Decompensation of viscera and low bone marrow function and hematopoietic function；
• Pregnant or lactating female patients;
• Expected survival time \< 3 months

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Tang-Du Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Henan Cancer Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Fujian Cancer Hospital: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting venous blood was drawn from patients who first received immune checkpoint inhibitors therapy before baseline and before cycle 3，5...2n+1.Then the blood samples were centrifuged and frozen in a refrigerator at -80℃ for later mass spectrometry analysis.

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hui Guo, PH.D

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Guo, PH.D

CONTACT

0086-13572824106; guohuihappy97@163.com

Xiaohui Jia

CONTACT

0086-19829393046; xiaohuijia0101@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 2, 2021
• Study Start: August 20, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 23, 2021

Record last verified: 2021-08