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:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT06895928
Eligibility Criteria:
Inclusion Criteria:
1. The age of signing the informed consent is 18 -70 years, regardless of gender.
2. At least one measurable lesion according to RECIST v1.1 criteria.
3. The ECOG score is 0 or 1.
4. Expected survival ≥12 weeks.
5. Good level of organ function.
6. Have the ability to give informed consent and to comply with the treatment plan.
7. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.
Exclusion Criteria:
1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases.
2. Spinal cord compression not cured by surgery and/or radiotherapy.
3. Subjects with uncontrolled tumor-related pain.
4. Received antitumor therapy within 4 weeks before the start of the study.
5. Subjects with severe cardiovascular and cerebrovascular disease.
6. History of immunodeficiency, including a positive HIV test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06895928
Study Brief:
Protocol Section:
NCT06895928