Status:
UNKNOWN
Exploration of the Predictive Marker and Establishment of Predictive Models of Checkpoint Inhibitor Pneumonitis
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Collaborating Sponsors:
Tang-Du Hospital
The First Affiliated Hospital of Zhengzhou University
Conditions:
Pneumonia, Interstitial
Eligibility:
All Genders
18+ years
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 f...
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.Pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT04734067
Start Date
August 20 2021
End Date
February 1 2025
Last Update
August 23 2021
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