Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 12:55 AM
NCT ID:
NCT04734067
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04734067
Study Brief:
Protocol Section:
NCT04734067