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

NCT ID: NCT04734067

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 440 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2025-02-01

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.

Detailed Description

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.

Conditions

Pneumonia, Interstitial

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

observational group

Patients receiving ICIs for the first time

Immune checkpoint inhibitors(ICIs) therapy

Intervention Type: OTHER

Patients with malignant tumors who first received ICIs

Interventions

Immune checkpoint inhibitors(ICIs) therapy

Patients with malignant tumors who first received ICIs

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Guo, PH.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Central Contacts

Hui Guo, PH.D

Role: CONTACT

guohuihappy97@163.com

0086-13572824106

Xiaohui Jia

Role: CONTACT

xiaohuijia0101@163.com

0086-19829393046

Other Identifiers

XJTU1AF2021LSK-001

Identifier Type: -

Identifier Source: org_study_id